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Dermatology Times®
Clinical Analysis for Today’s Skincare Specialists
September 2015 | VOL. 36, NO. 09 |
September 2015
Mind Matters
Volume 36 No. 09
Psychological factors associated
with skin disease are quantifiable
Clinical Analysis for Today’s Skincare Specialists
Most conditions that dermatologists see in their
offices impact their patients psychologically.
Similarly, psychiatric factors often are
instrumental in the etiology and course of certain
skin conditions, like skin picking (left) and prurigo
nodularis (below). It behooves dermatologists
to learn how to manage and when to refer these
patients. Photos: Francisco Tausk, M.D.
Cosmetic
Ingredient facts and
fallacies: What to know
to educate patients
Lisette Hilton | Staff Correspondent
Parabens. Phthalates. Chemical fragrances. Sodium lauryl sulfate. These
are among the behind-the-scenes ingredients in over-the-counter skincare
and haircare products that have some
of the big cosmetic companies chang-
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| THE TAKEAWAY | KELLY CORDORO, M.D., discusses screening labs, avoiding complacency, and the ABCDEs of melanoma in kids. SEE PAGE 86
Dermatology Times®
Clinical Analysis for Today’s Skincare Specialists
September 2015
Mind Matters
Volume 36 No. 09
Psychological factors associated
with skin disease are quantifiable
Clinical Analysis for Today’s Skincare Specialists
Most conditions that dermatologists see in their
offices impact their patients psychologically.
Similarly, psychiatric factors often are
instrumental in the etiology and course of certain
skin conditions, like skin picking (left) and prurigo
nodularis (below). It behooves dermatologists
to learn how to manage and when to refer these
patients. Photos: Francisco Tausk, M.D.
September 2015 | VOL. 36, NO. 09 |
Cosmetic
Ingredient facts and
fallacies: What to know
to educate patients
Lisette Hilton | Staff Correspondent
Parabens. Phthalates. Chemical fragrances. Sodium lauryl sulfate. These are
among the behind-the-scenes ingredients in over-the-counter skincare and
haircare products that have some of the
big cosmetic companies changing the
way they formulate moisturizers, soaps,
shampoos and anti-aging products.
But are these inactive ingredients bad
or are they merely perceived to be bad
because of misinformation or different
“spins” on the truth? And are their substitutes any better?
The science behind many of these
controversies is often misrepresented,
according to Adam Friedman, M.D.,
associate professor of dermatology, residency program director, and director of
translational research at George Washington University, Washington, D.C.
“You can easily find ways to demonstrate that these ingredients are toxic
using the certain bench assays, but
that doesn’t necessarily translate to the
INGREDIENTS see page 52
Lisette Hilton | Staff Correspondent
DermatologyTimes.com
Ignoring the elephant in the room —
the psychological aspects of skin disease
—can prevent traditional treatments from
working optimally or at all, according to
Caroline S. Koblenzer, M.D., a trained psychoanalyst and retired clinical professor of
dermatology, University of Pennsylvania.
Dr. Koblenzer says it became clear to her
soon after she started dermatology practice
in 1966 that dermatology wasn’t answering the needs of many patients with skin
conditions.
“If you have patients with eczema who are
not getting better, when medically speaking
they should be getting better, one begins to
ask questions,” Dr. Koblenzer says.
Those questions, according to the dermatologist, attempt to uncover the ways in
which psychological problems may be impacting the skin, or vice versa.
PSYCHOLOGICAL CONNECTIONS
Most conditions that dermatologists
see in their offices impact their patients
psychologically. In fact, some skin manifestations are almost entirely psychiatric, such as delusions of parasitosis, according to Richard D. Granstein, M.D.,
chairman of dermatology at Weill Cornell
Medical College and president of the Association of Psychoneurocutaneous Medicine of North America (APMNA), which is
the only organization in the United States
that focuses on psychodermatology issues.
“One could argue that there are skin
conditions that have little impact on psychology. Warts on the hands may not affect
psychological status unless very large, but
warts on the genitals probably do. Also, because many skin diseases are visible, even
if not contagious or life-threatening, they
PSYCHODERMATOLOGY see page 31
In This Issue
September 2015 VOL. 36, NO. 09
CLINICAL 18
Rosacea, the acne mimic
Critical factors you need to know for accurate
diagnosis and treatment
COSMETIC 44
Female
hair loss
Three pathways
and implications
for treatment
ONCOLOGY 61
Hh inhibitor therapy
Benefits, side effects, and alternatives for drug
resistance
BUSINESS 72
How to fire a problem patient
Expert recommendations for how to let go of
problem patients safely, effectively, humanely
| THE TAKEAWAY | KELLY CORDORO, M.D., discusses screening labs, avoiding complacency, and the ABCDEs of melanoma in kids. SEE PAGE 86
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EDITORIAL ADVISORY BOARD
Insight & Opinion From Our Advisory Board Leaders
Norman Levine, M.D.,
is a private practitioner
in Tucson, Ariz.
$
The tale of the 220 tube of clobetasol cream
patient with a minimally steroid-responsive dermatosis, vitiligo, recently contacted me to complain that he could no longer
afford the medication that I had prescribed for him. I was puzzled when he informed me that a 60-gram tube of clobetasol
cream would now cost him $220, an amount that was far beyond
his budget. The medication was no longer on his insurance plan’s formulary, presumably because it had become too expensive for them as well. At
first I was highly doubtful and assumed that the dispensing pharmacy had
mistakenly substituted a name-brand product for the generic version I had
prescribed. A quick survey of several local pharmacies confirmed that all
were pricing clobetasol above $200.
A
In this particular instance, I reluctantly
substituted fluocinonide cream for the
clobetasol, knowing that it was unlikely
that he would re-pigment while on this
therapy. To make matters worse, this new
medication was now being sold for about
$50.00 for a 60-gram tube. Six months
prior, it was one of the $4 specials at several drugstore chains.
This new economic reality strikes at the
heart of the service we dermatologists provide for our patients. If we can no longer use
medications that work best, we may revert
to second-rate status medically and only
marginally improve the lives of the people
we treat. In a conversation with a recently
trained colleague, he indicated that some of
his fellow residents intend on not writing any
prescriptions, but instead will provide only
surgical and cosmetic care. The rationale
for this decision is that it is simply too big of
a hassle to fight with third party payers who
are reluctant to allow expensive medications to be used by their insured customers.
If this approach to practice becomes widespread our specialty will be reduced to a
mere shadow of its former self. If dermatologists decide against treating skin conditions
with effective prescription medications, who
will be capable of treating complicated conditions?
Individuals with far more knowledge
than me have given several explanations including high costs of developing
new drugs, problems with manufacturing and the lack of profit in producing ge-
$
850
Methotrexate
tablets current
yearly cost,
compared to
$20/year per
33-dose vial
neric drugs as reasons for cost inflation.
In addition, the Affordable Care Act has
mandated that Medicare cannot negotiate
lower prices for the medications that they
provide. Therefore, drug manufacturers are
free to increase prices to astronomical levels without any controls. This is probably
what the 1880’s felt like when the robber
barons were at the peak of their powers.
What are we to do? I would strongly suggest that we do not give up on providing
our patients with the highest quality of care,
even when continuing the fight can be exasperating (I hate battling with third party payers over what they will or will not cover).
SANITY-SAVING STRATEGIES
There are several strategies which may
help to preserve our sanity and our
specialty.
Absolutely avoid name-brand
drugs whenever possible. Paying $2.25
per day for generic minocycline instead
of at least $6 per day for some branded
minocycline products can lead to real
savings over many months of treatment.
From another perspective, one often
hears the rationale that if the third-party
payer will cover such branded drugs,
why shouldn’t we prescribe them?
Those who make this argument fail to
understand that we all pay higher insurance premiums when more expensive
medications are used.
We can utilize medications in more
efficient ways: Triamcinolone cream
remains a real bargain but is not particularly potent. However, when used under
Saran occlusion or under wet wraps, it
becomes as potent as clobetasol. Often
a one-week use of occlusive dressings
improves the dermatitis to the point where
triamcinolone without the wraps will work
quite well.
Up until recently, methotrexate tablets
at a dose of 15 mg per week cost about
$300 per year, but now is at least $850
per year. However, if the medication can
be provided as the solution for injection
and ingested after being diluted in juice,
there can be very substantial savings. A
20 ml vial of methotrexate, 25 mg per ml,
costs less than $20. At a dose of 15 mg
per week (0.6 ml), there are 33 doses in a
single vial.
Fluorouracil cream costs at least $230
for a 40-gram tube. The vials of fluorouracil for injection cost about $5 per vial. By
placing the contents of one 50-mg vial into
30 ml of any emollient lotion, one gets approximately a 1.5% concentration, which
works as well as the store-bought variety.
If you want to be a very popular dermatologist, try giving this away to your patients
who need it.
Whatever strategies you employ to keep
treatments affordable, please avoid the
temptation to abandon this battle. Help
give your patients the best opportunity to
maximize the health of their skin. DT
3
4
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SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
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An 8-year-old girl was brought in by her
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Current and emerging
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LEGAL
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SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
David J. Goldberg, M.D., J.D.
is director of Skin Laser and Surgery
Specialists of New York and New
Jersey; director of laser research, Mount
Sinai School of Medicine; and adjunct
professor of law, Fordham Law School.
Moving to EMR and destroying
written records: I just got sued
r. Paper has practiced dermatology
for 20 years. Last year, he began to
implement an EMR system, and his
staff began to destroy thousands of paper
charts from the last two decades. Unfortunately, his staff shredded multiple records
that had not yet been scanned. Several
patients whose records were destroyed
have requested copies. One such patient
has now threatened to sue Dr. Paper for
negligence. He saw the patient only one
year ago. Does he have any liability?
D
SEVERAL ISSUES TO CONSIDER
Standard medical malpractice is based
on negligence. The analysis of negligence is based on four distinct elements:
➧
➧
➧
➧
Duty
Breach of duty
Causation
Damages
Attorneys, expert witnesses and juries
will always ask the same question:
In his actions toward his patient, did Dr.
Paper perform in accordance with reasonable duty?
In most jurisdictions the standard
question is: Did he perform his duty like
any other reasonable physician? In some
jurisdictions, the question is slightly different: Did the physician perform in a manner that would be expected by a reasonable patient? If Dr. Paper did not, he then
has breached his duty. Breaching his duty
will not necessarily cause him to lose a
lawsuit (it may, however, be the precipitating factor in the lawsuit being filed).
CAUSATION: CONNECTING THE DOTS
For Dr. Paper to lose the lawsuit, there
must be a connection between the breach
of duty and damages. That element is
known as causation. That is, was the
breach the actual cause of the damages?
Damages must have an economic
value. Misdiagnosis, scars, infection
and pigmentary changes may all have
economic value. In the end, all four elements in the cause of action in negligence must be proved to the jury for Dr.
Paper to lose the lawsuit.
Just because there are scars, infection, or pigmentary changes does not
mean there is also negligence. These may
be complications that do not necessarily rise to the level of negligence. Misdiagnosis, on the other hand, if it leads to
damages, may lead to a loss of the case
based on negligence. Whether there is a
breach in duty is often determined by a
testifying expert witness. Testimony will
be based on the medical literature, community norms, and meeting lectures.
RETAINING RECORDS
The second question is the more interesting one. The medical records have
been destroyed and so are no longer
available. It goes without saying that
we need to keep all records that relate
to our patients’ care, including notes,
communications, diagnostic test results
and medication records, for a variety of
medical and ethical reasons. For how
long do we need to keep the records?
The first level of regulation is federal.
Medicare’s Conditions of Participation
(which requires hospitals to retain records
for five years), applies only to facilities.
However, Medicare managed-care program providers have the longest retention
requirement under CMS regulations and
must retain patient records for 10 years.
HIPAA follows the Federal Statute of
Limitations for civil penalties and so requires retention of a record for six years
from the date of its creation or the date
when it last was in effect, whichever is later.
State requirements vary significantly. For example, physicians in New
York must keep the records of adult patients for six years after the last visit and
the records of minor patients until one
year after the child’s 18th birthday.
In Colorado, seven years is the adult
standard and, for minors, the records
should be kept until seven years after the
child has reached 18. Texas also uses
seven years as the adult standard and requires that the records of minors be kept
until they are 21 or for seven years from
the last date of treatment, whichever is
longer.
A physician who is closing a practice
entirely (rather than one who is selling,
under which terms the incoming physician
becomes the custodian of the records and
there is no time limit issue) must therefore
check her own state’s regulations. Needless to say, irrespective of any limiting
statutes, do not destroy medical records
that relate to a civil, criminal or administrative proceeding if you know that the process is either pending or already ongoing
but has not yet been resolved.
The majority of dermatologists have
been converting their written medical records to EMR records for a variety of reasons. The 2009 stimulus package allocated
billions of dollars to physicians upon implementation of “meaningful use” of EMR.
Dr. Paper has started down this road,
but he must be careful that written records are not destroyed before they’re
scanned. DT
State Your Case. What scenarios keep you guessing? Pass them along in confidence to: [email protected]
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
COMMENTARY
Step therapy stalls appropriate
patient treatment
GIL YOSIPOVITCH, M.D. | TEMPLE UNIVERSITY HEALTH SYSTEM
T
here has been a lot of discussion, here and nationwide, with the recent changes to health care in the
United States, about strategies to keep the cost of
prescription medicines down and the balance required
to ensure quality health care.
One such strategy, known as “step
therapy” or “fail-first,” is used by payers
to withhold coverage unless a healthcare
provider prescribes medications in a predetermined order. Step-protocols typically
require patients to fail on one or more
generic drugs, then one or more payerpreferred branded therapies, before they
can get a branded therapy not preferred
by the payer.
Policies of this sort are undermining
the treatment of patients with psoriasis in
Pennsylvania. The reasoning behind
step-therapy policies is often based on
financial, not medical, reasons. The requirements do not consider an individual’s
medical situation or history. And there are
few, if any, existing regulations that
require insurers to prove the safety and
efficacy of their step therapy policies.
With this process, insurance companies
are cutting down on costs but limiting
patients’ ability to get effective and
appropriate medications for their
individual situation.
In some cases, patients are required
to try and fail numerous medications that
may be inadequate for their particular situation. Patients may be required to take
medications they previously tried without
success, or that are contraindicated for
them based on their medical history.
As a result, step therapy policies can
severely delay access to a therapy a doctor deems is best-suited for the patient. In
the course of these delays, patients’
disease may worsen. For up to 20% of
patients, step therapy can even result in
not receiving treatment at all.
As a dermatologist who treats many
patients with sometimes severe psoriasis,
I know that finding an effective medicine
with an appropriate side effect profile for
a given patient is no easy process. And
yet, despite my years of medical training, my medical judgement and my relationship with my patient are being undermined with step therapy.
failure and kidney disease. Although therapies called TNF inhibitors are inappropriate for someone with these health problems, his insurance company is pushing
me to prescribe them for his psoriasis.
It’s not surprising, then, that step therapy policies place a large administrative
burden on physicians like me and other
health care staff. We have to contact insurance companies to determine whether
a prescribed medication will be covered
or to file an appeal if the medication is denied. This burden, in turn, takes time away
from patient care.
STAMP OUT STEP THERAPY
Step therapy policies
can severely delay
access to a therapy a
doctor deems is bestsuited for the patient.
Particularly frustrating is the requirement by some insurance companies that
patients “step through” psoriasis medicines that have black box warnings —
meaning they may cause potentially severe side effects, even including tuberculosis. As a physician, I have pledged first
to “do no harm.” So how can I be required
to prescribe these types of medicines to
patients for whom they are inappropriate?
For example, I have a patient with HIV
and severe psoriasis. Given his dampened
immune system, I would not prescribe an
immune-suppressing medicine that could
lead to severe infections. Yet his insurance
company refuses to cover a newer, more
appropriate oral therapy that lacks these
potential side effects, despite my appeals.
Or take my patient with chronic heart
It’s time to do something about step
therapy. Some states are working on
legislation that seeks to regulate step
therapy protocols and ensure they are
safe for patients. Illinois, for example,
is currently debating House Bill 3549,
which would ensure step therapy programs are based on clinical guidelines developed by independent experts, guarantee that the exceptions
process is transparent and accessible
to patients and health care providers,
and establish a framework for when it
is medically appropriate to exempt patients from step therapy.
Pennsylvania needs to consider similar legislature.
Of course we should not be wasting our
health care dollars. There has to be some
regulation, or the system will be bankrupt.
But final decisions should not be made by
a representative of a regulatory agency
who has not examined the patient and
who does not understand his or her specific concerns. They should be made by
the physicians who have the appropriate
education, experience and knowledge. DT
Disclosures: Gil Yosipovitch, M.D., is professor and
chair, department of dermatology; director Temple
Itch Center, Temple University Health System
Read Dr. Norman Levine’s commentary on: Third party payer pain and sanity-saving strategies, PAGE 3
15
IRREGULAR
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Sarah Kasprowicz, M.D.
is clinical assistant professor at the
University of Chicago’s Pritzker School
of Medicine and a physician with
NorthShore University HealthSystem.
Tea tree oil uses and side effects
ea tree oil is an essential oil that is
obtained through steam distillation
of the leaves of the native Australian coastal tree, Melaleuca alternifolia.
M. alternifolia is an evergreen shrub with
needle-like leaves that grows from 5 to
8 meters in height. Tea tree oil has been
used in a wide variety of medicinal applications from coughs and colds to skin
infections.1 Relevant to dermatology, tea
tree oil can be found in over-the-counter
soaps, astringents and shampoos and is
typically added to these products for its
antimicrobial properties.
T
(MRSA). One study compared treatment with mupirocin 2% nasal ointment,
chlorhexidine 4% soap and silver sulfadiazine 1% cream versus a tea tree oil
regimen that included a tea tree oil 10%
cream and tea tree oil 5% body wash.
infections such as bacterial and fungal
conditions and molluscum, as well as inflammatory conditions such as acne. A
common “home remedy” patients will
often ask about is whether or not there is
a role for tea tree oil in treating nail fungus. Tea tree oil has been shown to have
activity against dermatophytes, in vitro.5
And, in some studies, it has been shown
to be clinically effective in treating onychomycosis and interdigital tinea pedis
as compared to placebo.6, 7
Topical tea tree oil has also been looked
at for application in acne therapy.
In one study, topical tea tree oil was
shown to be superior to placebo in acne
treatment.8 Another study compared tea
tree oil with benzoyl peroxide and found
them to be similarly effective, but tea tree
oil was better tolerated by acne patients.9
Tea tree oil has also
been shown to have
antibacterial activity
against MRSA.
ANTIMICROBIAL AGENT, MRSA FIGHTER
There have been a number of papers
describing the antiseptic properties of
tea tree oil, which has potential antibacterial activity through disruption of bacterial membranes. 2 Terpin-4-ol is the
component of tea tree oil that is thought
to exhibit the anti-microbial activity. 3
Tea tree oil has also been shown to
have antibacterial activity against methicillin-resistant Staphylococcus aureus
There was no significant difference in efficacy between the two programs and
both were shown to be effective against
MRSA.4 Tea tree oil-containing products
can be recommend to patients as adjunct
treatments in MRSA therapy.
FACTORS TO CONSIDER
FUNGUS AND ACNE
Studies are available that show promising application for various dermatologic
Properties of tea tree oil
ANTIMICROBIAL A number of studies have been performed and
published that identify tea tree oil as an effective antiseptic agent.
1
2
ANTIFUNGAL Tea tree oil has been shown to be effective
in treating onchomycosis and interdigital tinea pedis.
IRRITANT Use with caution: tea tree oil
can cause contact dermatitis. OTC
preparations are not well controlled
for concentration and purity.
3
GETTY IMAGES/IMAGEMORE CO, LTD.
16
®
BORDER
It is often hard to identify the concentration and purity of tea tree oil in over-thecounter products so caution should be
used in solely relying on these products
for bacterial eradication. In addition,
it is important to counsel patients that
tea tree oil can be very irritating and a
source of allergic contact dermatitis.10
It is thought that 1,8-cineole is likely the
compound in tea tree oil that causes
dermatitis. Because tea tree oil may
have an irritant effect, it is also worth
considering for the treatment of molluscum contagiosum.11
Patients should be counseled to use
tea tree oil with caution given the rate
of irritant and contact dermatitis. In addition, it should be used with caution in
children and pregnant or breastfeeding women and tea tree oil is not for oral
ingestion as oral poisoning in children
and adults has been observed.3 DT
For references go to
bit.ly/Teatreepatients
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© 2015 Unilever
TOPICORT® (desoximetasone) Topical Spray, 0.25%
Rx Only
BRIEF SUMMARY
1 INDICATIONS AND USAGE
Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age
or older.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Effect on Endocrine System
Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitaryadrenal (HPA) axis.
Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential
for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical
corticosteroid.
In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis,
adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area
(BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray
twice a day for 28 days. [see Clinical Pharmacology (12.2)]
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be
periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to
HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use
of occlusive dressings, altered skin barrier, liver failure and young age.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the
frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require
supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon
discontinuation of topical corticosteroids.
Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic
absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic
corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in
Specific Populations (8.4)]
5.2 Local Adverse Reactions with Topical Corticosteroids
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency
corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness,
folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary
infection, and miliaria. Some local adverse reactions may be irreversible.
5.3 Allergic Contact Dermatitis with Topical Corticosteroids
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal
rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch
testing.
5.4 Concomitant Skin Infections
Concomitant skin infections should be treated with an appropriate antimicrobial agent.
If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been
adequately treated.
5.5 Flammable Contents
Topicort® Topical Spray is flammable; keep away from heat or flame.
ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque
psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects
applied Topicort® Topical Spray.
Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site
dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).
Another less common adverse reaction (<1% but >0.1%) was folliculitis.
Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1%
Number of Subjects with
Adverse Reactions
Topicort® Topical Spray,
0.25% b.i.d. (N = 149)
Vehicle spray b.i.d.
(N = 135)
13 (8.7%)
18 (13.3%)
Application site dryness
4 (2.7%)
7 (5.2%)
Application site irritation
4 (2.7%)
5 (3.7%)
Application site pruritus
3 (2.0%)
5 (3.7%)
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels.
Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by
subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray
based on a body surface area comparison.
8.3 Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical
administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in
breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort® Topical
Spray is administered to a nursing woman.
If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion
by the infant.
8.4 Pediatric Use
Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied;
therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body
mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when
they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insufficiency during and/
or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of
topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)]
HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial
hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal
suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
[see Warnings and Precautions (5.1)]
8.5 Geriatric Use
Clinical studies of Topicort® Topical Spray did not include sufficient numbers of subjects aged 65 years and over
to determine whether they respond differently from younger subjects. Other reported clinical experience has
not identified differences in responses between the elderly and younger patients. In general, dose selection for
an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
10 OVERDOSAGE
Topicort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and
Precautions (5.1)]
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information and Instructions for Use)
Inform patients of the following:
G (?1@45?9105/-@5;:-?05>1/@10.E@41<4E?5/5-:
G ';<5/;>@® Topical Spray is for external use only. Avoid use on the face, axilla or groin.
G ;:;@A?1@45?9105/-@5;:2;>-:E05?;>01>;@41>@4-:@4-@2;>C45/45@C-?<>1?/>5.10
G ;:;@.-:0-31;>;@41>C5?1/;B1>;>C>-<@41@>1-@10?75:?;-?@;.1;//8A?5B1
G %1<;>@-:E?53:?;28;/-8;>?E?@195/-0B1>?1>1-/@5;:?@;@41<4E?5/5-:
G ;:;@A?1;@41>/;>@5/;?@1>;50/;:@-5:5:3<>;0A/@?C5@4';<5/;>@® Topical Spray without first consulting with
the physician.
G 5?/;:@5:A1@41>-<EC41:/;:@>;85?-/451B102:;59<>;B191:@5??11:C5@45:C117?/;:@-/@
the physician.
G '45?9105/-@5;:5?flammable; avoid heat, flame, or smoking when applying this product.
G 5?/->0@45?<>;0A/@0-E?-2@1>05?<1:?10.E<4->9-/5?@
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: April 2013
AD100-0030
18
CLINICAL
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
OF SILVER-BASED
26 BENEFITS
CLOSED DRESSINGS
Advances in burn care for kids
CHALLENGES
28 HERPES
Ubiquitous and sometimes atypical,
derms need to be on the lookout for HHV
Rosacea, the acne mimic
LISETTE HILTON | STAFF CORRESPONDENT
QUICK READ
Many patients have no idea that
Nearly half of rosacea patients thought
what they think is acne is really
they had acne before being diagnosed,
rosacea. Even some dermaaccording to a new patient survey. It’s
tologists misdiagnose this
a finding that doesn’t surprise dermatricky masquerader.
tologist Doris Day, M.D., who practices
in Manhattan, N.Y.
Ohio, and Dermatology Times edito“When I tell patients they have rosarial advisory board member.
cea, they still think of it as a form of acne
“Rosacea is not just on the midface.
and don’t understand how it can
Often patients have rosacea on
happen now, when they didn’t
the scalp, chest and back,”
1/2
have it in the past as they
Dr. Torok says. “These
of rosacea
were growing up. When
a re not considered
I mention they have
common a reas for
patients report feeling
rosacea, I ask them if
rosacea. Dermatolounattractive, 42% say
gists might diagnose
they know what rosathey’re embarrassed and
the rosacea as folcea is and most of them
30% feel less confident
liculitis or acne and
don’t know. So, we’re
not educating patients
treat it with clindabecause of the skin
properly on what they
mycin and tretinoin,
condition.
have and what it means,”
which, unfortunately, is
Dr. Day says. “Patients canirritating and ineffective.”
not wrap their minds around
how something that looks like acne is
CONSUMERS UNAWARE,
UNLIKELY TO SEEK CARE
not acne.”
Even dermatologists misdiagnose
In May 2015, Galderma Laboratories and
rosacea, according to Helen M. Torok,
the National Rosacea Society released
M.D., medical director, Trillium Creek
findings of a national survey1 reflectDermatology and Surgery, Medina,
ing responses from 500 rosacea patients
Quotable
and 300 dermatologists, which found:
Half of rosacea patients report feeling unattractive, 42% say they’re embarrassed and 30% feel less confident
because of the skin condition. More
than half of patients don’t feel comfortable talking to their physicians about
these emotional challenges. And, while
nearly half of doctors say they want hear
about their patients’ feelings, only 12%
of patients believe this to be true.
There’s a lot that patients don’t understand about rosacea. Most don’t know
about key rosacea triggers. Twentythree percent of patients try to cover
up symptoms with cosmetics, but otherwise aren’t treating their symptoms.
Nearly 30% say they aren’t doing anything to treat their rosacea; yet, 56% of
doctors said they wish patients would
more proactively manage rosacea.
EDUCATION NEEDED,
BUT DO DERMS HAVE TIME?
Dr. Day says patients who think they
have acne often try to treat the condition
with over-the-counter acne products,
many of which irritate rosacea.
“We’re dealing with a condition
ROSACEA see page 21
DTExtra
Atypical presentations are
something that we need to
acutely keep in mind when
contemplating diagnosis
and appropriate therapy
and management of
affected individuals.”
Warren R. Heymann, M.D.
Camden, N.J.
Discussing the ubiquitous quality of HHV
SEE STORY PAGE 28
FOR THE FIRST TIME, people with psoriasis
and psoriatic arthritis can contribute directly
to the future of research into these chronic,
systemic autoimmune diseases through the
National Psoriasis Foundation’s patient-centered
research network called Citizen Pscientist. An
online, interactive community, Citizen Pscientist
allows people living with psoriasis to connect
with researchers, share their data and get input
from others in the community, and ultimately
drive the direction of psoriatic disease research.
Source: www.citizenpscientist.org
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
CLINICAL DERMATOLOGY
ROSACEA:
Helping your patients with triggers and treatments from page 18
“When I tell patients they have rosacea,
they still think of it as a form of acne
and don’t understand how it can
happen now, when they didn’t
have it in the past as they were
growing up.”
that’s very common and is somewhat
unpredictable,” Dr. Day says.
Patients don’t always go to the dermatologist for their rosacea as their main
complaint; rather, they might be in the
office for other things and the dermatologist notices it. If the dermatologist brings
up the rosacea and educates patients
about what it is, providing information
Doris Day, M.D.
about triggers and treatment, it can be
a lengthy discussion that can add to the
office visit time, according to Dr. Day.
nents of rosacea. Also I believe it helps
redness component of the skin conNevertheless, Dr. Day initiates disdition, brimonidine topical gel (Mircontrol ocular rosacea, which I think
cussions with her patients about rosavaso, Galderma) is the only drug that is
is underdiagnosed and undertreated.”
cea and anything else she sees that she
FDA approved to reduce the redness of
can treat.
rosacea.
AND DERMS NEED TO BE AWARE….
“I make sure to point out the posi“I have 14 different devices in my ofOne aspect of rosacea that might not
tives in their skin, but I also pay attenfice. I can offer intense pulsed light
be on dermatologists’ radar, action to areas where they could take betor pulse dye laser to reduce the
cording to Dr. Torok, is that
ter care to minimize risks of skin canredness. But those are not
rosacea can present as
Nearly
cer and signs of aging and to optimize
covered by insurance and
only a flush, which is the
30% say they
their skin health. I tell patients that I see
have to be repeated over
er y t hematotela naren’t doing anything
what’s happening and these are the cortime. Some people may
g iec t at ic subt y pe.
to treat their rosacea; yet,
rective steps I can take to help their skin
have a tan or too much
Treating these patients
look its best. I think it is important for
color and they aren’t
with topical metroni56% of doctors said they
patients to understand they have some
candidates for the dedazole, topical iverwish patients would more
control over rosacea,” says Dr. Day.
vices,” says Dr. Day.
mectin or an oral anproactively manage
Trigger education is particularly imAnother drug, ivertibiotic doesn’t work as
rosacea.
portant, according to Dr. Torok.
mectin (Soolantra, Galwell because there are no
“The number one trigger for rosacea
derma), is a new category
papules or pustules to treat,
of drug to treat roDr. Torok says, noting that “they
are environmental—heat and exsacea, according to
don’t have the inflammatory comtreme cold. Emotions, including
More
Dr. Day.
ponent other than the flushing.”
stress, are another big trigger.
than 1/2 of
“ We’v e h ad
Exercising and lifestyle acThe best approach with these patopic a l mettivities trigger it. And taktients, according to Dr. Torok, is to
patients don’t feel
ing a lot of niacin in vitaronidazole
first explain what triggers their rosacomfortable talking to their
mins can aggravate roin different
cea, including environmental factors
physicians about these emotional
sacea,” Dr. Torok says.
concent raand stress.
challenges. And, while nearly half
“So, you have to ask:
t ions a nd
Lasers can eliminate the redness, ofWhat are you taking?
I like metfering a more permanent solution. Briof doctors say they want hear
monidine controls the flushing but is
What are you doing?
ron id a z ole
about their patients’ feelings,
temporary and must be reapplied, acWhat is your lifestyle?
topica l, but
only 12% of patients
cording to Dr. Torok. DT
What is your environthis is 1% iverbelieve this to be
ment?”
mectin cream,
so it’s a brand new
Disclosures: Dr. Torok has no relevant disclosures.
true.
Dr. Day is a consultant for Galderma.
TODAY’S TREATMENTS
drug for the breakNew rosacea treatments address the
outs of rosacea,” Dr. Day
different components of the skin consays. “Other things that we’ve had and
References:
1. http://www.rosacea.org/press/national-surveydition, including redness, the breakstill use are Oracea (doxycycline, Galreveals-rosacea-sufferers-often-hide-behindouts and ocular rosacea.
derma). I’ve been taking Oracea for a
cosmetics-treating-condition
While lasers and light therapies relong time, and I put my patients on it
main the gold standard for treating the
because I believe it helps all the compoP A T I E N T R E S O U R C E S ❯ Patients can learn more about rosacea using the following resources
❯ The National Rosacea Society http://www.rosacea.org. ❯ The American Academy of Dermatology’s web page for consumers with rosacea https://www.
aad.org/dermatology-a-to-z/diseases-and-treatments/q---t/rosacea. ❯ Galderma Laboratories and the National Rosacea Society have launched the Break
Up with Your Makeup campaign, which offers survey findings and information about rosacea treatment. http://breakupwithmakeup.com.
21
Simulated image based on locally advanced BCC patient at Week 24.
Boxed Warning and Additional
Important Safety Information
Embryo-Fetal Toxicity
<$5('21,650(&+$1,502)$&6,214,8('*(&$1
cause embryo-fetal death or severe birth defects
when administered to a pregnant woman. Erivedge
is embryotoxic, fetotoxic, and teratogenic in animals.
Teratogenic effects included severe midline defects,
missing digits, and other irreversible malformations
< (4,);34(*1$1&;56$6752))(0$/(52)4(342'7&6,8(
potential within 7 days prior to initiating Erivedge
therapy. Advise females of reproductive potential to
use effective contraception during and after Erivedge
therapy. Advise males of the potential risk of Erivedge
exposure through semen and to use condoms with a
pregnant partner or a female partner of reproductive
potential. Advise pregnant women of the potential
risks to a fetus
E/@4=0108,70;,>409>=,9/108,70;,<>90<=:18,70
patients to contact their healthcare provider with a
known or suspected pregnancy. Report pregnancies to
Genentech at (888) 835-2555
Female Patients
E/@4=0108,70=:1<0;<:/?.>4@0;:>09>4,7>:?=00110.>4@0
contraception during therapy with Erivedge and for
7 months after the final dose
Male Patients
E/@4=08,70=:1>30;:>09>4,7<4=6>:,908-<C::<10>?=
if a female partner of reproductive potential is exposed
>:<4@0/20/@4=08,70;,>409>=>:?=0.:9/:8=A4>3
a pregnant partner or a female partner of reproductive
potential, even after a vasectomy, during therapy and for
3 months after the final dose of Erivedge
Blood Donation
E/@4=0;,>409>=9:>>:/:9,>0-7::/:<-7::/;<:/?.>=
while receiving Erivedge and for 7 months after the final
dose of Erivedge
Semen Donation
E)4=8:/024-4=;<0=09>49=0809>4=9:>69:A941>30
amount of vismodegib in semen can cause embryo-fetal
3,<8/@4=08,70;,>409>=9:>>:/:9,>0=0809/?<492
and for 3 months after the final dose of Erivedge
For your patients with advanced basal cell carcinoma go with
A PROVEN HEDGEHOG PATHWAY INHIBITOR
ERIVEDGE: Oral, Once-Daily Dosing
E Due to the nature of aBCC and its clinical factors (ie, lesion recurrence, location/size,
and invasiveness) some patients may not be candidates for surgery or radiation1,2
E Erivedge is an oral treatment option dosed as a 150-mg capsule once daily until disease
progression or unacceptable toxicity3
Erivedge reduced lesions in patients with aBCC1,3
Objective response rates (ORR) by IR from ERIVANCE1,3*
ORR
(95% CI)
Complete response
Partial response
Median duration of response (months)
(95% CI)
laBCC (n=63)
mBCC (n=33)
43% (n=27)
(30.5-56.0)
30% (n=10)
(15.6-48.2)
21% (n=13)
22% (n=14)
0%
30% (n=10)
7.6
7.6
(5.7-9.7)
(5.6-NE)
Indication
Erivedge® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults
with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred
following surgery or who are not candidates for surgery, and who are not candidates for radiation.
*Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Locally advanced BCC
patients were considered responders if they did not experience progression and had ≥30% reduction in lesion size (sum of the
longest diameter) from baseline in target lesions by radiography or in externally visible dimensions of target lesions (scar tissue
was measured); or had complete resolution of ulceration in all target lesions. Complete response was objective response with no
residual BCC on sampling biopsy. Partial response was objective response with presence of residual BCC on sampling biopsy. In the
metastatic BCC cohort, response was assessed according to RECIST version 1.0. Complete response was disappearance of all target
and nontarget lesions. Partial response was ≥30% decrease in SLD of target lesions from baseline.
IR=Independent Review; laBCC=locally advanced BCC; mBCC=metastatic BCC; CI=confidence interval; NE=not estimable;
RECIST=Response Evaluation Criteria in Solid Tumors; SLD=sum of the longest diameter.
Lactation
E":/,>,,<0,@,47,-70<02,</492>30;<0=09.0:1@4=8:/024-
in human milk, the effects of the drug on the breastfed
infant, or the effects of the drug on milk production.
Because of the potential for serious adverse reactions in
breastfed infants from Erivedge, advise a nursing woman
that breastfeeding is not recommended during therapy with
Erivedge and for 7 months after the final dose
Adverse Reactions
E'308:=>.:88:9,/@0<=0<0,.>4:9=H
A0<08?=.70
spasms, alopecia, dysgeusia, weight loss, fatigue, nausea,
diarrhea, decreased appetite, constipation, arthralgias,
vomiting, and ageusia
E809:<<30,.,9:..?<49108,70=:1<0;<:/?.>4@0;:>09>4,7
Reversibility of amenorrhea is unknown. In clinical trials,
a total of 3 of 10 premenopausal women developed
amenorrhea while receiving Erivedge
E'<0,>809>080<209>2<,/07,-:<,>:<C,-9:<8,74>40=
observed in clinical trials were hyponatremia in 6 patients
(4%), hypokalemia in 2 patients (1%), and azotemia in
3 patients (2%)
+:?8,C<0;:<>=4/00110.>=>:>30,>
:<
www.fda.gov/medwatch. You may also report side effects to
Genentech at (888) 835-2555.
See what you can offer your patients with
aBCC at Erivedge.com
References: 1. &06?74.!42/09!%#<:0>,7N Engl J Med.
2012;366(23):2171-2179. 2. Walling HW, et al. Cancer Metastasis
Rev. 2004;23(3-4):389-402. 3. Erivedge® (vismodegib) capsule
Prescribing Information. Genentech, Inc. May 2015.
Please see brief summary of Prescribing
Information on following page for a complete
discussion of the risks associated with Erivedge,
including the BOXED WARNING.
G
0909>0.3(&9.77<423>=<0=0<@0/
%
$<49>0/49(&
Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC
Patients
1
All aBCC Patients (N = 138)
ERIVEDGE® (vismodegib) capsule
Initial U.S. Approval: 2012
This is a brief summary of information about ERIVEDGE. Before
prescribing, please see full prescribing information.
WARNING: EMBRYO-FETAL TOXICITY
ERIVEDGE can cause embryo-fetal death or severe birth
defects when administered to a pregnant woman. ERIVEDGE is
embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic
effects included severe midline defects, missing digits, and other
irreversible malformations.
Verify the pregnancy status of females of reproductive potential
within 7 days prior to initiating ERIVEDGE therapy. Advise
females of reproductive potential to use effective contraception
during and after ERIVEDGE therapy. Advise males of the potential
risk of ERIVEDGE exposure through semen and to use condoms
with a pregnant partner or a female partner of reproductive
potential. Advise pregnant women of the potential risks to a
fetus. [See Warnings and Precautions (5.1, 5.3), Use in Specific
Populations (8.1, 8.3)].
1
INDICATIONS AND USAGE
ERIVEDGE capsule is indicated for the treatment of adults with metastatic
basal cell carcinoma, or with locally advanced basal cell carcinoma that
has recurred following surgery or who are not candidates for surgery,
and who are not candidates for radiation.
2
DOSAGE AND ADMINISTRATION
The recommended dose of ERIVEDGE is 150 mg taken orally once daily
until disease progression or until unacceptable toxicity [see Clinical
Studies (14)].
Grade 3
(%)
Grade 4
(%)
Gastrointestinal disorders
Nausea
Diarrhea
Constipation
Vomiting
42 (30.4%)
40 (29.0%)
29 (21.0%)
19 (13.8%)
1 (0.7%)
1 (0.7%)
-
-
General disorders and
administration site conditions
Fatigue
55 (39.9%)
7 (5.1%)
1 (0.7%)
Investigations
Weight loss
62 (44.9%)
10 (7.2%)
-
Metabolism and nutrition
disorders
Decreased appetite
Infertility
Females
Amenorrhea can occur in females of reproductive potential. Reversibility
of amenorrhea is unknown [see Adverse Reactions (6)].
35 (25.4%)
3 (2.2%)
-
8.4 Pediatric Use
The safety and effectiveness of ERIVEDGE capsule have not been
established in pediatric patients.
Musculoskeletal and
connective tissue disorders
Muscle spasms
Arthralgias
99 (71.7%)
22 (15.9%)
5 (3.6%)
1 (0.7%)
-
Nervous system disorders
Dysgeusia
Ageusia
76 (55.1%)
15 (10.9%)
-
-
Skin and subcutaneous
tissue disorders
Alopecia
88 (63.8%)
-
-
1
aBCC = Advanced Basal Cell Carcinoma.
2
MedDRA = Medical Dictionary for Regulatory Activities.
3
Grading according to NCI-CTCAE v3.0.
Amenorrhea:
In clinical trials, a total of 3 of 10 pre-menopausal women developed
amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology
(13.1)].
Laboratory Abnormalities:
If a dose of ERIVEDGE is missed, do not make up that dose; resume
dosing with the next scheduled dose.
Treatment-emergent Grade 3 laboratory abnormalities observed in
clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2
patients (1%), and azotemia in 3 patients (2%).
CONTRAINDICATIONS
None.
5
WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Toxicity
Based on its mechanism of action, ERIVEDGE can cause embryo-fetal
death or severe birth defects when administered to a pregnant woman.
In animal reproduction studies, vismodegib was embryotoxic, fetotoxic,
and teratogenic at maternal exposures lower than the human exposures
at the recommended dose of 150 mg/day.
Verify the pregnancy status of females of reproductive potential within 7
days prior to initiating ERIVEDGE therapy. Advise females of reproductive
potential to use effective contraception during therapy with ERIVEDGE
and for 7 months after the final dose. Advise male patients to use
condoms, even after a vasectomy, to avoid potential drug exposure in
pregnant partners and female partners of reproductive potential during
therapy and for 3 months after the final dose of ERIVEDGE. Advise
pregnant women of the potential risk to a fetus [see Use in Specific
Populations (8.1, 8.3) and Clinical Pharmacology (12.1)].
5.2 Blood Donation
Advise patients not to donate blood or blood products while receiving
ERIVEDGE and for 7 months after the final dose of ERIVEDGE.
5.3 Semen Donation
Vismodegib is present in semen. It is not known if the amount of
vismodegib in semen can cause embryo-fetal harm. Advise male
patients not to donate semen during and for 3 months after the final
dose of ERIVEDGE [see Use in Specific Populations (8.1, 8.3)].
6
ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may
not reflect the rates observed in clinical practice.
ERIVEDGE capsule was administered as monotherapy at doses ≥ 150
mg orally daily in four open-label, uncontrolled, dose-ranging or fixed
single dose clinical trials enrolling a total of 138 patients with advanced
basal cell carcinoma (BCC). The median age of these patients was 61
years (range 21 to 101), 100% were White (including Hispanics), and
64% were male. The median duration of treatment was approximately
10 months (305 days; range 0.7 to 36 months); 111 patients received
ERIVEDGE for 6 months or longer.
The most common adverse reactions (≥ 10%) were muscle spasms,
alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased
appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).
7
Males
Vismodegib is present in semen [see Clinical Pharmacology (12.3)].
It is not known if the amount of vismodegib in semen can cause
embryo-fetal harm. Advise male patients to use condoms, even after
a vasectomy, to avoid drug exposure to pregnant partners and female
partners of reproductive potential during therapy with and for 3 months
after the final dose of ERIVEDGE. Advise males of the potential risk to an
embryo or fetus if a female partner of reproductive potential is exposed
to ERIVEDGE. Advise males not to donate semen during therapy with and
for 3 months after the final dose of ERIVEDGE.
MedDRA Preferred Term2
All Grades3
(%)
ERIVEDGE may be taken with or without food. Swallow capsules whole.
Do not open or crush capsules.
4
Specific Populations (8.1)]. Advise females of reproductive potential to
use effective contraception during therapy and for 7 months after the
final dose of ERIVEDGE.
DRUG INTERACTIONS
In repeat-dose toxicology studies in rats, administration of oral
vismodegib resulted in toxicities in bone and teeth. Effects on bone
consisted of closure of the epiphyseal growth plate when oral vismodegib
was administered for 26 weeks at ≥ 50 mg/kg/day (approximately
≥ 0.4 times the systemic exposure (AUC) in patients at the recommended
human dose). Abnormalities in growing incisor teeth (including
degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in
the dental pulp, ossification of the root canal, and hemorrhage resulting
in breakage or loss of teeth) were observed after administration of oral
vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in
patients at the recommended human dose).
8.5 Geriatric Use
Clinical studies of ERIVEDGE capsule did not include sufficient numbers
of patients aged 65 and over to determine whether they respond
differently from younger patients.
8.6 Hepatic Impairment
No dose adjustment is required in patients with hepatic impairment [see
Clinical Pharmacology (12.3)].
8.7 Renal Impairment
No dose adjustment is required in patients with renal impairment [see
Clinical Pharmacology (12.3)].
Clinically relevant pharmacokinetic interactions are not expected
between vismodegib and a substrate, inducer or inhibitor of cytochrome
450 enzymes or an inhibitor of P-glycoprotein (P-gp) or between
vismodegib and gastric pH elevating agents [see Clinical Pharmacology
(12.3)].
10
8
17
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its mechanism of action and animal reproduction studies,
ERIVEDGE can cause fetal harm when administered to a pregnant woman
[see Clinical Pharmacology (12.1)]. In animal reproduction studies, oral
administration of vismodegib during organogenesis at doses below the
recommended human dose resulted in embryotoxicity, fetotoxicity, and
teratogenicity in rats [see Data]. There are no human data on the use of
ERIVEDGE in pregnant women. Advise pregnant women of the potential
risk to a fetus. Report pregnancies to Genentech at 1-888-835-2555.
The background risk of major birth defects and miscarriage for the
indicated population is unknown. In the U.S. general population, the
estimated background risk of major birth defects and miscarriage in
clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data
Animal Data
In an embryo-fetal developmental toxicity study, pregnant rats were
administered vismodegib orally at doses of 10, 60, or 300 mg/kg/day
during the period of organogenesis. Pre- and post-implantation loss
were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times
the systemic exposure (AUC) in patients at the recommended human
dose), which included early resorption of 100% of the fetuses. A dose
of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the
recommended dose) resulted in malformations (including missing
and/or fused digits, open perineum and craniofacial anomalies) and
retardations or variations (including dilated renal pelvis, dilated ureter,
and incompletely or unossified sternal elements, centra of vertebrae, or
proximal phalanges and claws).
8.2 Lactation
No data are available regarding the presence of vismodegib in human
milk, the effects of the drug on the breastfed infant, or the effects of the
drug on milk production. Because of the potential for serious adverse
reactions in breastfed infants from ERIVEDGE, advise a nursing woman
that breastfeeding is not recommended during therapy with ERIVEDGE
and for 7 months after the final dose.
8.3 Females and Males of Reproductive Potential
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential within 7
days prior to initiating ERIVEDGE therapy.
Contraception
Females
Based on its mechanism of action and animal data, ERIVEDGE can
cause fetal harm when administered to a pregnant woman [see Use in
OVERDOSAGE
There is no information on overdosage in humans. In clinical trials,
ERIVEDGE capsule was administered at 540 mg orally once daily;
exposure did not increase between 150 mg and 540 mg daily.
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Administration Instructions
t "EWJTFQBUJFOUTUPTXBMMPX&3*7&%(&DBQTVMFTXIPMFBOEOPUUPDSVTI
or open the capsules.
Embryo-Fetal Toxicity
t "EWJTFQSFHOBOUXPNFOPGUIFQPUFOUJBMSJTLUPBGFUVT<TFFWarnings
and Precautions (5.1) and Use in Specific Populations (8.1)].
t "EWJTFGFNBMFTPGSFQSPEVDUJWFQPUFOUJBMUPVTFFGGFDUJWFDPOUSBDFQUJPO
during therapy with and for 7 months after the final dose of ERIVEDGE
[see Warnings and Precautions (5.1) and Use in Specific Populations
(8.1, 8.3)].
t "EWJTF NBMFT FWFO UIPTF XJUI QSJPS WBTFDUPNZ UP VTF DPOEPNT
to avoid potential drug exposure in both pregnant partners and
female partners of reproductive potential during therapy with and
for 3 months after the final dose of ERIVEDGE [see Warnings and
Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].
t "EWJTFGFNBMFQBUJFOUTBOEGFNBMFQBSUOFSTPGNBMFQBUJFOUTUPDPOUBDU
their healthcare provider with a known or suspected pregnancy.
Report pregnancies to Genentech at 1-888-835-2555 [see Warnings
and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].
Semen Donation
t "EWJTF NBMFT OPU UP EPOBUF TFNFO EVSJOH UIFSBQZ XJUI BOE GPS months after the final dose of ERIVEDGE.
Lactation
t "EWJTFXPNFOUIBUCSFBTUGFFEJOHJTOPUSFDPNNFOEFEEVSJOHUIFSBQZ
with ERIVEDGE and for 7 months after the final dose [see Use in
Specific Populations (8.2)].
Blood Donation
t "EWJTF QBUJFOUT OPU UP EPOBUF CMPPE PS CMPPE QSPEVDUT XIJMF UBLJOH
ERIVEDGE and for 7 months after the final dose of ERIVEDGE.
ERIVEDGE® [vismodegib] capsule
Manufactured by:
Patheon, Inc.
Mississauga, Canada
Distributed by:
ERIVEDGE is a registered trademark
Genentech USA, Inc.
of Genentech, Inc.
A Member of the Roche Group
©2015 Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
ERI/050115/0063
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
CLINICAL DERMATOLOGY
Rosacea’s psychological impact
BILL GILLETTE | STAFF CORRESPONDENT
The results of a mult i-count r y
s u r v e y a p p e a r t o c on f i r m t h e
belief that rosacea — including facial
erythema — negatively affects a person’s
psychological and emotional wellbeing
(Dermatology and Therapy).
Researchers in Germany, Italy, the
United Kingdom and Canada designed
the survey to assess the impact of
facial er y thema on subconscious
perceptions and initial reactions of
others and how these affect their
resu lt i ng at t it udes. T he su r ve y
also measured the impact of facial
erythema on an individual’s emotional
and psychological health.
Participants were shown photos of
people with and without facial erythema who were representative of the
participants’ country or region. They
were asked to accept or discard descriptive words shown next to each
image — for example, trustworthy, relaxed, healthy, tired — with the speed
of each response directly linked to the
participant’s initial, subconscious perception of the face. According to the
study, this provided quantitative and
qualitative data that the researchers
could analyze and interpret at various levels of complexity.
In addition to a traditional questionnaire, all participants who had self-reported facial erythema during recruitment were asked to answer questions
about how the condition affects their
day-to-day life.
WHAT RESEARCHERS FOUND
Survey results showed that respondents
strongly associated facial erythema with
poor health and negative personality
traits, with participants reporting negative impacts of rosacea emotionally,
socially and in the workplace. Nearly
80% reported difficulty in controlling
facial erythema; however, those with
physician-diagnosed rosacea had significantly improved control compared
with those whose rosacea was undiagnosed (39% versus 20%, respectively).
“This survey shows that first impressions are a powerful driver of perception,” the authors write. “People suffering with facial erythema associated
with rosacea not only have to man-
age their own psychological barriers
to cope with the disease but also deal
with the prejudice and perceptions
of others. Facial erythema tends to
generate a negative first impression
and has a negative impact on people
both personally and
professionally. The
results highlight the
need to treat t hose
with facial erythema
of rosacea from both a
physiological and psychosocial perspective
— treating not only
t he physical sy mptoms, but a lso t he
person experiencing
the symptoms.”
GET TO THE ROOT
Dermatolog y Times
asked Omaha, Neb.,
der matolog i st a nd
E d itor ia l Adv isor y
Board member Joel
Schlessinger, M.D.,
to comment on this
international survey.
“Rosacea clea rly
impacts the self-conf idence of i nd iv iduals,” he says. “The
problem is that rosacea, as a disease, is
so poorly characterized that our patients
are not always treated
in the correct way by
dermatologists. Marketing has replaced
medical information,
and we now have a
lo w er e x p e c t at ion
for results that relies
more on simply treating the effect of rosacea — the redness —
rather than focusing
on the cause.
“In add it ion to
t reat ments such as
l a s er s a nd topic a l
creams, it is even more
important to find out
the cause when possible,” Dr. Schlessinger
adds.
“ T h e t a k e -h o m e m e s s a g e i s
t hat rosac ea i sn’t ju st a c overi t-u p p r o c e s s — i t r e q u i r e s a
significant thought process on the
part of the dermatologist in order to
consider it fully addressed.” DT
25
26
CLINICAL
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Advances in burn care for kids
LOUISE GAGNON | STAFF CORRESPONDENT
The use of closed dressings for wounds
has dramatically altered the wound
care provided for injuries from burns
in the pediatric setting, according to
the Medical Director of the Burn Unit
of the Hospital for Sick Children in
Toronto, Canada.
Speak ing at a pediatric wound
care sy mposium in Toronto, Joel
Fish, M.D., F.R.C.P.C., a plastic surgeon and associate professor in the
Department of Surgery and Research
Director for t he Div ision of Plastic Surgery at the University of Toronto in Toronto, notes that silverbased products and a closed dressing
technique have advanced pediatric
wound care such that fewer dressings
are required and lengths of stay in
hospital have decreased.
“The way that the silver materials
are now formulated, they bond to different materials allowing (the dressing) to remain active for a number of
days and changes what we do in pediatric burns units,” says Dr. Fish.
Dr. Fish explains that dressings
such as the Aquacel® Ag are adherent
and the outer dressing has no drainage, so patients can be sent home
with the dressings on and are later
able to soak off the dressings.
Dr. Fish was involved with a retrospective case-matched comparison
study where patients were treated
w it h t he Aquacel Ag dressing for
partial thickness wounds. Patients
were matched to historical controls
in terms of variables like age and affected body surface area. Scalds were
source of most of the burns, w ith
f lames and oil being the source of
the balance of the burns.
Investigators compared outcomes
with the closed dressings to outcomes
without closed dressings, looking at
QUICK READ
The use of closed dressings in
pediatric wound care has shortened
hospital stays, decreased dressing
changes, and lessened the need for
feeding tubes and pain medication.
measures like the number of dressing changes, the need for surger y,
the number of outpatient dressings,
medication use related to pain relief
for dressing changes, and the need
for satellite anesthesia.
There was a significant decrease
in the use of anesthesia between patients with the Aquacel AG dressing and control subjects, as well as
an increase in the number of procedures and dressing changes for control subjects. Duration of stays for inpatients was 9 days for patients who
wore Aquacel AG closed dressings
and 14 days for in-patients who did
not wear closed dressings.
Despite technolog y advances in
dressings, clinicians cont inue to
change dressings frequently and so
put pediatric patients through unnecessary pain, according to Dr. Fish.
“Unfortunately, we still hear about
[practices] at pediatric hospitals in
Ontario, of children going in for daily
dressing changes,” says Dr. Fish. “We
know that is well below the standard
of care. It’s not appropriate to change
a dressing daily on a child or even
more often than daily for what is arguably a painful acute wound.”
T he i nve s t ig at ion fou nd t h at
patients who did not have a closed
d res si ng appl ie d u nder went 14
dressings while those who wore the
Aquacel AG dressing underwent 3
dressing changes. “That is a huge difference,” says Dr. Fish. “The multiplier effect of performing a dressing
change in the population of pediatric burn patients in hospital is huge.
Burn care dressings compared
Duration of hospital stay
Dressing changes
With silver-based
closed dressings
9 days
3
With traditional dressings
14 days
14
Indeed, more dressing changes
means more supplies, more medication to provide pain relief, more nursing staff on site, and adverse events
like inadequate bowel function due to
morphine intake, explains Dr. Fish.
Even once discharged from hospital, those patients who underwent the
closed dressing technique required
fewer dressing changes, notes Dr. Fish.
“The way that the
silver materials are
now formulated,
they bond to
different materials
allowing (the
dressing) to
remain active for
a number of days
and changes what
we do in pediatric
burns units.”
Joel Fish, M.D., F.R.C.P.C.
University of Toronto, Toronto
One of the most significant outcomes, if not the most significant, is
that length of stay was decreased with
the closed dressing technique, and that
change in practice has sustained this
outcome, stresses Dr. Fish. Another
outcome is that patients who underwent the closed dressing technique experienced less weight loss than their
counterparts who did not have that
technique administered, and they required fewer feeding tubes.
Even though there has been a steady
climb in the number of admissions to the
burn unit at the Hospital for Sick Kids,
the direct cost of caring for a patient has
fallen because of the implementation of
the closed dressing technique. DT
Dr. Fish has no relevant disclosures.
Pure Hydration.
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and all day moisture retention
Various molecular forms of hyaluronic acid penetrate skin and lock in moisture while a
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For more information visit topixpharm.com or call 800-445-2595.
Partners in advancing the commitment to healthy, beautiful skin
28
CLINICAL
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
The challenge of atypical herpes presentations
ILYA PETROU, M.D. | STAFF CORRESPONDENT
AAD meeting, San Francisco – Human
herpes viruses are ubiquitous pathogens among humans that can establish
latent infections in their host and reactivate to produce recurrent disease.
This scenario is particularly true in
immunocompromised patients. Each
virus is associated with a set of typical
clinical signs and symptoms; however,
atypical presentations are common and
recognizing the atypical presentations
of these viruses is key to arriving at a
timely diagnosis and appropriate therapy in affected patients.
“Most of us can become infected at
some point with any of the human herpes viruses throughout our lifetime.
They can manifest in different ways,
depending on the clinical circumstance and, especially, on the degree
of immunosuppression one may have.
It’s the atypical presentations of these
herpes infections that we have to keep
in the forefront and be wary of in our
patients,” says Warren R. Heymann,
M.D., Professor of Medicine and Pediatrics and Head of the Division of Dermatology at the Cooper Medical School
of Rowan University, Camden, N.J.
QUICK READ
Human herpes viruses are
ubiquitous and they should be kept
in mind for atypical presentations
in immunocompromised hosts.
“Atypical presentations are something that we need to acutely keep in
mind when contemplating diagnosis
and appropriate therapy and management of affected individuals. The
astute clinician must be wary of these
atypical presentations, such as an
unusual ulcer recalcitrant to standard
therapy,” Dr. Heymann says.
Sometimes atypical presentations of
herpes simplex can look verrucous or
can be chronic, according to Dr. Heymann, making them suspicious of another disease process or infection, such
as HPV infection. The keys to clinical diagnosis in those circumstances might be
to look carefully at the border to see if the
lesion is scalloped or not. Dr. Heymann
says that atypical presentations have
to be at the forefront of lesions that are
not healing in immune compromised
hosts, which can be seen in HSV-1 infections, as well as in cytomegalovirus
infections in terms of perianal ulcerative
lesions. Epstein-Barr virus infection is
Clinicians need to thoroughly follow up on
any unusual lump or bump that might be
an atypical presentation of an associated
lymphoproliferative malignancy in either
a post-transplant patient or other immune
compromised host.
ATYPICAL PRESENTATIONS
Of the over 100 herpes viruses that exist,
humans are most commonly affected by
the human herpes viruses 1 to 8. The typical clinical presentations of these viruses
are readily recognized by experienced
clinicians and well documented in the
literature, but the atypical presentations
that these viruses may cause, particularly
in the immunocompromised host, can
sometimes be challenging to quickly
recognize and accurately diagnose in
the clinical setting.
seen acutely in mononucleosis but it is
also being increasingly implicated in
the association with Lipschütz ulcers.
Furthermore, the virus is also increasingly being linked to many different
disorders including several lymphomas
(other than Burkitt’s lymphoma) such
as hydroa vacciniforme-type associated lymphomas as well as lymphomas
linked to hypersensitivity from mosquito
bites. Dr. Heymann emphasizes that clinicians need to thoroughly follow up on
any unusual lump or bump that might
be an atypical presentation of an associated lymphoproliferative malignancy in
either a post-transplant patient or other
immune compromised host.
“It is sometimes easy not to think of
HHV infections in these scenarios because of the atypical presentations. No
one is going to miss grouped vesicles
on an erythematous base. However, it
would be easy to miss a non-healing
chronic ulcer and not think about HHV
infection. Similarly, it’s easy to not think
about the potential role of the EpsteinBarr virus if you have an atypical nodule
that may be a lymphoma in the elderly.
It is important that we get into the habit
and mindset of thinking about these viruses when they are atypical and in the
right context,” says Dr. Heymann.
EVOLVING THERAPIES
New and evolving therapies are slowly
making headway in the management
of HHV infections, Dr. Heymann says,
witnessed by the drop in frequency of varicella zoster virus infections. According to
Dr. Heymann, the ongoing research for
potential vaccines for the Epstein-Barr
virus would be especially important
going forward in immunosuppressed
patients to potentially prevent the subsequent lymphomas that can occur. Most
recently, the roseola virus is increasingly
being associated with its potential role
in DRESS syndrome, a drug reaction in
part characterized by eosinophilia and
systemic symptoms or drug-induced
hypersensitivity.
“There is a lot going on in terms of the
recognition of atypical presentations of
these viruses in immune-compromised
patients, their disease associations as
well as potential therapeutic measures.
We have to be aware of these changes on
the horizon that may alter our approach
to patients who are at risk of complications, especially lymphoproliferative
complications,” Dr. Heymann says.
Dr. Heymann advises that clinicians
should consider performing appropriate laboratory tests in these settings,
which could include biopsy as well as
viral culture and serologies because
there may be certain circumstances
when treating the viral infection may be
of immediate benefit to the patient. DT
Dr. Heymann has no relevant disclosures
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Teledermatology helps
patients help themselves
BILL GILLETTE | STAFF CORRESPONDENT
Telemedicine, the remote delivery and
follow-up of medical services and clinical data via telecommunications technology, is as widely practiced in dermatology as it is in any medical discipline—
indeed, teledermatology has become a
term unto its own.
As noted by the American Telemedicine Association, “Teledermatology is
one of the most active applications of
telemedicine rendered in the United
States. Dermatology is particularly
suited to the use of advanced communication technologies and the internet
for delivery of care. By using advanced
communication technologies, dermatologists are able to widen their reach
to patients in a cost-effective manner.”
Dermatologist Iltefat Hamzavi,
M.D., can testify to that. As a physician at Hamzavi Dermatology and affiliate Dermatology Specialist Group
in Michigan, Dr. Hamzavi has made a
specialty of treating adolescents with
acne—and one of his most effective
tools is teledermatology.
ter compliance—and if there’s no compliance, there are no results.”
Dr. Hamzavi says he never uses teledermatology for the first visit—that’s
always done face-to-face. But for follow-ups, he says, teledermatology is
very effective.
“At least with this particular demographic, the adolescent acne patient,
teledermatology allows for carrying out
a treatment plan pretty much on their
own time,” Dr. Hamzavi says. “Young
people these days, more so than older
generations, are very comfortable with
communicating and interacting online—some even prefer it.”
That’s especially true for more introverted or self-conscious young acne patients, who may feel more free to communicate their concerns, ask questions, have
their acne scars assessed and track their
treatment—things they might feel less
comfortable about in a face-to-face visit.
An area of compliance that Dr.
Hamzavi has found problematic—and
for which teledermatology is no magic
bullet—is the taking of the acne drug
isotretinoin. Because it is a fat-soluble
“Dermatology is particularly suited
to the use of advanced communication
technologies and the internet for
delivery of care.”
American Telemedicine Association
A MATCH FOR TEEN PATIENTS
“The value of teledermatology, especially
in its use with adolescent acne patients,
is that it allows them to do what they
have to do in terms of compliance on
their own schedule, and gives the physician a non-intrusive means by which
to communicate with the patient to ensure compliance,” Dr. Hamzavi tells Dermatology Times. “With teledermatology,
young people feel more at ease, they feel
more like they’re on their own turf, and
don’t have to take time away from work
or school to meet with their doctor. I’ve
found that this connection allows for bet-
medication, guidelines call for isotretinoin to be taken along with a high-fat
meal, which isn’t particularly healthy
and can be an obstacle to compliance
for some patients. Dr. Hamzavi suggests
the use of isotretinoin-Lidose, which
enhances absorption, but also says the
problem can be handled simply by suggesting the patient take the isotreinoin
with a glass of milk or some French fries.
As for the role of teledermatology, Dr.
Hamzavi emphasized that there are no
studies to show that it may be the wave of
the future for improving compliance—
though he is considering taking up such
a study. Studies have shown, however, that
satisfaction is high with teledermatology as
compared with office-based visits.
NOT JUST FOR YOUNG PATIENTS
“I am a proponent of teledermatology,” says
Helen M. Torok, M.D., Trillium Creek Dermatology in Medina, Ohio. “I use it to interact with patients when they call and have
an urgent problem. We exchange pictures
and diagnoses, and I often will call in prescriptions based on what was viewed on the
text message. We use our patient portals in
a similar manner.”
Patients love it, she says—and not just
young patients. “Some of my patients are off
in Florida in the winter or on vacation, and
they are enthralled with the ease, efficiency
and connection to their dermatologist—they
literally have their skin doc in their pocket!”
Dr. Torok says. “I find that patients in the 39to 50-year-old range really love it, use it and
appreciate it more than teenagers.”
UNBIASED REGULATIONS NEEDED
Omaha, Neb., dermatologist Joel Schlessinger,
M.D., says that while he’s intrigued by teledermatology and the opportunities it may
offer, the dermatologic community needs
to proceed thoughtfully before jumping on
the bandwagon.
“For now, there are many unanswered
questions and concerns,” he says. “One
such concern is the ownership of teledermatology and promulgation of rules governing it by the same individuals. While
ownership implies having a stake in the
game, it also could lead to a lack of governance and preferential status for those
companies with representatives on the
boards and in study groups.”
Dr. Schlessinger says he thinks teledermatology will become more popular—“and
even essential”—in the years ahead.
“But we want to have a strong basis in fair
and unbiased regulations,” he says. “Additionally, given the huge importance that dermatology could have in this area, our specialty should drive the discussion and offer
constructive advice to marshal the process
through and assist with patient safety considerations.” DT
Disclosures: Dr. Hamzavi is an advisor for and has an ownership interest in MyDerm Portal
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
CLINICAL DERMATOLOGY
31
PSYCHODERMATOLOGY:
A link revealed between emotion and condition from page 1
have a special ability to interfere with
interpersonal relationships,” Dr. Granstein says.
Another example of the mind-skin
association is trichotillomania. This is
a condition in which patients will pull
out their hair, either with or without
their conscious awareness. If patients
could stop pulling their hair out, they
certainly would, Dr. Koblenzer says.
“Patients feel ashamed and humiliated by their inability to control the
action, and embarrassed by the appearance. It became clear to me that
there was more to this than met the
eye,” she says. “The skin problems
that we see are a psychological defense against the patients recognizing that there are emotional problems. I’m not suggesting that this is
so in every patient, by any means,
but certainly so in those patients who
do not respond to treatment as one
would anticipate.”
ECZEMA AND EMOTIONS
Dr. Koblenzer coauthored a study on
the topic of eczema and emotions in
1988, in the Archives of Dermatology. She
found that there was a lack of therapeutic
response in a proportion of children
with intractable eczema. The authors
demonstrated that this ongoing lack of
response could be attributed to dysfunctional parent-child relationships,
which affected the physical and emotional development of the child. Dr.
Koblenzer illustrated cases of infantile
eczema in which aggressive dermatologic measures were combined with a
psychological approach, and that this
helped the parents to recognize and
deal with their conflict.
“Rapid and sustained improvement
in skin, emotional development, and
social adjustment resulted,” Dr. Koblenzer wrote.
stress but appears to be precipitated
or exacerbated by stress. The proportion of patients reporting emotional
triggers varies with the disease, ranging from approximately 50% (acne) to
greater than 90% (rosacea, alopecia
areata, neurotic excoriations, and
lichen simplex) and may be 100%
for pat ients w it h hy perhidrosis.
St ress ma nagement, rela x at ion
techniques, benzodiazepines, and
PSYCHODERMATOLOGY see page 32
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STRESS AND SKIN DISEASE
Psychiatric factors often are instrumental in the etiology and course of
skin conditions, according to a study by
Mohammad Jafferany, M.D., a dermatologist and psychiatrist and adjunct assistant professor in psychiatry and behavioral sciences at Central
Michigan University, Saginaw, Mich.
“The skin disease is not caused by
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32
CLINICAL
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Figure 1 Degrees of skin picking
span normal to psychotic behavior.
A teenager picking acne lesions
might be regarded as normal, but
patients who deform their
appearance by skin picking
and develop significant
hyperpigmentation and scarring
are not behaving normally.
Photos: Francisco Tausk, M.D.
PSYCHODERMATOLOGY:
One-third of patients have significant emotional problems from page 31
selective serotonin reuptake inhibitors (SSRIs) have been found useful
in these disorders,” according to the
study published in 2007 in the Primary Care Companion in the Journal of Clinical Psychiatry.
Francisco Tausk, M.D., professor
of dermatology and psychiatry, department of dermatology University
of Rochester, Rochester, NY, and former APMNA president, said studies
have suggested that about one third
of patients who come to dermatology
clinics have significant emotional
problems associated with their skin
conditions.
“The problem is that, as dermatologists, we don’t address that issue. Some
of the problems stem from the fact that
diseases like psoriasis or eczema are
very visible and therefore significantly
impact your sense of being, social
interactions, intimacy, etc. That’s one
aspect of these diseases — that psychological problems stem from skin
disease,” Dr. Tausk says. “The other
side of the coin is represented by skin
diseases that are the product of psy-
Spreading the
Knowledge
“Patients feel ashamed and humiliated
by their inability to control the action,
and embarrassed by the appearance. It
became clear to me that there was more
to this than met the eye.”
Caroline S. Koblenzer, M.D.
Retired clinical professor of dermatology, University of Pennsylvania; former APMNA president
chiatric illness; the most common example is skin picking.”
There are degrees of skin picking,
according to Dr. Tausk, spanning normal to psychotic behavior. A teenager picking acne lesions might be
regarded as normal. But patients who
deform their appearance by skin picking and develop significant hyperpigmentation and scarring are not behaving normally.
People with impulse control disorder who pick their skin know they’re
doing it but can’t stop, he says. “These
patients may spend up to six hours a
day in front of the mirror using their
fingers or a number of instruments
such as tweezers,” Dr. Tausk says.
At the far end of the spectrum are
patients that have no awareness that
they’re picking their skin.
“They deny this emphatically. They
come with numerous ulcerations on
their skin, sometimes extending to
most of the body surface, Dr. Tausk
says. “Then, there are patients that
suffer from delusions, and have the
PSYCHODERMATOLOGY see page 35
Made up of dermatologists, psychiatrists, psychologists and allied health
professionals, the Association of Psychoneurocutaneous Medicine of North America
(APMNA) is dedicated to promoting the awareness of psyche and skin interaction and the
role of psychoneuroimmunology in skin diseases, according to the Association’s website.
Dermatologists who visit the site will find research on the topic, news about upcoming
meetings, member information and more.
For more information, go to http://apmna.org.
Help your patients with facial erythema of rosacea experience...
Not an actual patient. Individual results may vary. Results are simulated to show a 2-grade improvement of erythema. At hour 12 on day 29, 22% of subjects
using Mirvaso Gel experienced a 2-grade improvement of erythema compared with 9% of subjects using the vehicle gel.*
RAPID AND SUSTAINED ERYTHEMA REDUCTION
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t The first and only FDA-approved topical treatment specifically developed and indicated for the facial erythema of rosacea1
t Fast results that last up to 12 hours1
t The most commonly reported adverse events in controlled clinical studies included erythema (4%), flushing (2%), skin-burning
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Important Safety Information
Indication: Mirvaso® (brimonidine) topical gel, 0.33% is an alpha-2 adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema
of rosacea in adults 18 years of age or older. Adverse Events: In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin-burning
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ingestion of Mirvaso Gel by children have been reported. Keep Mirvaso Gel out of the reach of children. Not for oral, ophthalmic, or intravaginal use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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See for yourself. Visit www.mirvaso.com/hcp.
*Phase 3 clinical studies of 553 subjects 18 and older. Subjects were randomized 1:1 to either Mirvaso Gel or vehicle for 29 days. Subjects and clinicians were asked to grade the improvement they saw at 30 minutes and
hours 3, 6, 9, and 12 following application.
†
Each gram of gel contains 5 mg of brimonidine tartrate equivalent to 3.3 mg of brimonidine free base.
IMPORTANT INFORMATION ABOUT
®
Mirvaso
(Brimonidine) Topical Gel, 0.33%*
*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base
BRIEF SUMMARY
This summary contains important information about MIRVASO (Mer-VAY-Soe)
Gel. It is not meant to take the place of the full Prescribing Information.
Read this information carefully before you prescribe MIRVASO Gel. For full
Prescribing Information and Patient Information please see package insert.
WHAT IS MIRVASO GEL?
MIRVASO (brimonidine) Topical Gel, 0.33% is a prescription medicine that
is used on the skin (topical) to treat facial redness due to rosacea that does
not go away (persistent).
WHO IS MIRVASO GEL FOR?
MIRVASO Gel is for use in adults ages 18 years and older.
WHAT WARNINGS AND PRECAUTIONS SHOULD I BE AWARE OF?
MIRVASO Gel should be used with caution in patients that:
B
B
B
B
B
B
B
B
B
have depression
have heart or blood vessel problems
have dizziness or blood pressure problems
have problems with blood circulation or have had a stroke
have dry mouth or Sjögren’s Syndrome
have skin tightening or Scleroderma
have Raynaud’s phenomenon
have irritated skin or open sores
are pregnant or plan to become pregnant. It is not known if MIRVASO Gel
will harm an unborn baby.
B are breastfeeding. It is not known if MIRVASO Gel passes into breast milk.
You and your female patient should decide if she will use MIRVASO Gel or
breastfeed. She should not do both.
Ask your patient about all the medicines they take, including prescription
and over-the-counter medicines, skin products, vitamins and herbal
supplements. Using MIRVASO Gel with certain other medicines may affect
each other and can cause serious side effects.
Keep MIRVASO Gel out of the reach of children.
If anyone, especially a child, accidentally swallows MIRVASO Gel, they
may have serious side effects and need to be treated in a hospital. Get
medical help right away if you, your patient, a child, or anyone else
swallows MIRVASO Gel and has any of these symptoms:
MIRVASO Gel can lower blood pressure in people with certain heart or
blood vessel problems. See “What warnings and precautions should I be
aware of?”
These are not all of the possible side effects of MIRVASO Gel. Remind your
patients to call you for medical advice about side effects.
You are also encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
HOW SHOULD MIRVASO GEL BE APPLIED?
B Remind your patients to use MIRVASO Gel exactly as you instruct them.
They should not use more MIRVASO Gel than prescribed.
B Patients should not apply MIRVASO Gel to irritated skin or open wounds.
B Important: MIRVASO Gel is for use on the face only. Patients should not
use MIRVASO Gel in their eyes, mouth, or vagina. They should also avoid
contact with the lips and eyes.
B Instruct your patients to see the detailed Instructions for Use that come
with MIRVASO Gel for information about how to apply MIRVASO Gel
correctly.
GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF
MIRVASO GEL
Remind your patients not to use MIRVASO Gel for a condition for which it
was not prescribed and to not give MIRVASO Gel to other people, even if they
have the same symptoms. It may harm them.
WHAT ARE THE INGREDIENTS IN MIRVASO GEL?
Active Ingredient: brimonidine tartrate
Inactive Ingredients: carbomer homopolymer type B, glycerin,
methylparaben, phenoxyethanol, propylene glycol, purified water, sodium
hydroxide, titanium dioxide.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT MIRVASO GEL?
B Go to www.mirvaso.com or call 1-866-735-4137
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Revised: August, 2013
HCP
B Lack of energy, trouble breathing or stops breathing, a slow heart beat,
confusion, sweating, restlessness, muscle spasms or twitching.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF MIRVASO GEL?
The most common side effects of using MIRVASO Gel include:
B redness, flushing, burning sensation of the skin, skin irritation
Skin redness and flushing may happen about 3 to 4 hours after applying
MIRVASO Gel. Ask your patients to tell you if they get skin redness and
flushing that is uncomfortable.
References: 1. Fowler J Jr, Jackson JM, Moore A, et al; Brimonidine Phase III Study Group. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of
rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12(6):650-656. 2. Mirvaso [package insert]. Galderma Laboratories, L.P. Fort Worth, TX; 2013.
Mirvaso and Galderma are registered trademarks.
©201 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
MIR-164B Printed in USA 0/1
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
CLINICAL DERMATOLOGY
Figure 2. Acne
excoriée is a
form of skin
picking in which
patients with
acne cannot
stop picking and
squeezing acne
lesions.
Photos: Francisco Tausk,
M.D.
PSYCHODERMATOLOGY:
Stress is a quantifiable component from page 32
conviction that they have parasites
coming out of their skin (called delusions of parasitosis).
In many of these cases, cutaneous
treatments don’t help enough or at
all. Therapies vary considerably depending on the level of insight into
the self-harming behavior.
“If the patient has conscience that
they’re producing their own disease,
then it’s much easier to treat, usually
with the addition of cognitive behavioral or psychotherapy. If patients
adamantly deny their role in the selfinjurious behavior — they say they
wake up in the morning and there’s
a hole in their face — then they need
antipsychotics,” Dr. Tausk says. “The
problem is that these patients will
never go to a psychiatrist because
they insist that they don’t have any
psychological problems. Since you
cannot refer them to a psychiatrist, it
behooves the dermatologist to start
treatment. So, the dermatologist has
to have knowledge of basic psychotropic treatments to be able to get
the patient started. Once the delusion improves, those patients can be
then referred to a psychiatrist.”
ARE DERMATOLOGISTS PREPARED?
I n a s t u d y D r. J a f f e r a n y a n d
colleagues published in July 2010 in
the International Journal of Derma-
tology, researchers assessed the level
of training in, and awareness and
attitude about, psychocutaneous
disorders among dermatologists. A
mail-in survey was sent to all members of Washington State Dermatology Society. They were asked to provide information on demographic
Studies have
suggested that
about one third
of patients
who come to
dermatology clinics
have significant
emotional
problems
associated
with their skin
conditions.
Francisco Tausk, M.D.
U n i v e r s i t y o f R o c h e s t e r, R o c h e s t e r, N Y;
former APMNA president
variables; level of training, skills,
and degree of comfort in managing
psychodermatologic disorders; referral patterns, knowledge of patient
and family resources on psychodermatology; and interest in continuing medical education on psychocutaneous disorders, according to the
study’s abstract.
One hundred and t wo dermat olo g i s t s r e s p onde d . O f t ho s e,
18% reported a clear understandi ng of ps y c hoder m atolog y a nd
42% of the respondents reported
being ver y comfor table in diagnosing and treating psychocutaneous disorders. About 90% of those
responding were not aware of any
patient or family resources on psychodermatology. Nearly 40% expressed
interest in attending any kind of continuing medical education activity
on psychodermatologic disorders,
according to the study.
Dr. Koblenzer’s nearly 50 years in
practice have focused on caring for
patients with a psychological aspect
to their skin disorder. In the United
States, Dr. Koblenzer is a rare breed.
The former APMNA president says that
the American health system leaves
little room for talking with patients
about their psychological health.
Exploring possible psycholog ica l
PSYCHODERMATOLOGY see page 36
35
36
CLINICAL
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
PSYCHODERMATOLOGY:
Are dermatologists prepared to help these patients? from page 35
ties to skin disease in patient care, research and education have not taken
hold in the United States. There is the
APMNA, but growing its membership
and getting dermatologists and others
to attend meetings has been a challenge, she says.
“This is something that I think is
inefficient in our system. The Europeans have really taken [psychodermatology] seriously. When the British
formed a society similar to the APMNA,
within one year, they had 100 mem-
Other Resources
Psychodermatology: A Guide
to Understanding Common
Psychocutaneous Disorders,
by Mohammad Jafferany, M.D.
This review focuses on
classifying and describing
treatment recommendations for
psychocutaneous disorders,
including psoriasis, atopic
dermatitis, acne excoriée,
hyperhidrosis, urticaria, herpes,
dermatitis artefacta, delusions
of parasitosis, trichotillomania
and others.
[Jafferany M. Psychodermatology:
a guide to understanding common
psychocutaneous disorders. Prim
Care Companion J Clin Psychiatry.
2007;9(3):203-13.]
Psycho-cutaneous Disease,
published in 1987 by Grune &
Stratton and written by Caroline S.
Koblenzer, M.D.
This book, which is written from
a psychoanalytic perspective,
is available through Amazon in
paperback.
Clinical Management
in Psychodermatology, published
in 2009 by Springer, authored by
Wolfgang Harth, Uwe Gieler, Daniel
Kusnir and Francisco A. Tausk.
bers. The APMNA, after more than 10
years, still has only about 15 or 20 members. There is a very different attitude
in this country. The Scandinavians
have been very active and many of the
European countries have produced
real research. I would have to say that
up until now we have not. Anything
that I have written, and I have published 80-some papers, have all been
really observational rather than strictly
scientific,” Dr. Koblenzer says.
Dermatologists who promote psychodermatology battle the mental health
stigma. Mental health is not a popular topic, even among most dermatologists, according to Dr. Tausk. He recalls
organizing a course for residents on the
basics of psychodermatology some 10
years ago. Residents could attend for
free. It was the day before the American
Academy of Dermatology meeting, and
at the same location of the meeting.
“Finally, I canceled it. … only three
people signed up,” he says. “This disinterest in the topic is not the same in
other countries. For example, we organized a symposium on psychodermatology the day before the World Congress in 2008 in Buenos Aires, and we
had more than 200 people there.”
Dermatology residencies don’t prepare U.S. dermatologists in the area
of psychodermatolog y, according
to Dr. Jafferany. Dr. Jafferany, executive secretary of APMNA, says the
association is working on getting a psychodermatology curriculum in dermatology residency programs.
“Some dermatologists are trying
to treat these patients, but, obviously,
you have to have training or knowledge or be able to recognize psychiatric
complements in these patients. Cream,
ointments and dermatologic medications do not help these people,” Dr.
Jafferany says.
One way to learn more, according to
Dr. Jafferany, is through the APMNA.
Launched in 1989, the APMNA holds its
annual meeting the day before and at
the location of the American Academy
of Dermatology each year. APMNA’s
objectives are to promote the awareness of psychocutaneous medicine;
hold meetings, seminars and symposia on psychodermatology; facilitate
the introduction of psychodermatol-
ogy curriculum into dermatology and
psychiatry residency programs; and
provide support to patients and parents on psycho-dermatological disorders. Interested dermatologists can attend meetings (held every other year)
in Europe by the European Society of
Dermatology and Psychiatry.
MAKING PSYCHE PART OF PRACTICE
Dermatologists’ awareness that dermatology and psychiatry are interwoven is an important first step, according to these experts.
Other steps are for dermatologists
to learn more about how to manage
and when to refer these patients by attending meetings and reading journal articles. A greater awareness about
psycho-dermatology and acceptance
in the specialty could lead to more
widespread learning in residencies.
“Many physicians, including myself, when presented with a patient
with skin disease will often focus quite
narrowly on the skin findings alone”
Dr. Granstein says. “However, I think
one should always keep in mind how
that skin disease affects the ability
of the patient to relate to others and,
more generally, how that skin disease
might affect the patient’s psychological well-being.” DT
REFERENCES
Koblenzer CS, Koblenzer PJ. Chronic intractable atopic eczema. Its occurrence as a physical sign of impaired parent-child relationships
and psychologic developmental arrest: improvement through parent insight and education. Arch Dermatol. 1988;124(11):1673-7. Review
Jafferany M. Psychodermatology: a guide to
understanding common psychocutaneous disorders. Prim Care Companion J Clin Psychiatry. 2007;9(3):203-13
Gupta MA, Gupta AK. Psychodermatology: an update. J Am Acad Dermatol. 1996
Jun;34(6):1030-46. Review.
Jafferany M, Vander Stoep A, Dumitrescu A,
Hornung RL. The knowledge, awareness, and
practice patterns of dermatologists toward
psychocutaneous disorders: results of a survey study. Int J Dermatol. 2010 Jul;49(7):784-9.
Comments?
Give Dermatology Times your
feedback by contacting us at
[email protected].
42
CLINICAL DERMATOLOGY
Using psychological
assessments
Expert offers insight on tools to supplement
skin disease diagnosis, management
BILL GILLETTE | STAFF CORRESPONDENT
Why should dermatologists worry about psychological assessment tools in their practice? Pamela Schell
Werschler, Psy.D., M.S.N., A.R.N.P., D.N.C., answered this
question in her presentation, “Survey of Assessment Tools
in Dermatologic Practice,” at the recent inaugural Aesthetic + Medical Dermatology Symposia, held in Coeur
d’Alene, Idaho, in May.
According to Dr. Werschler, a psychologist and nurse
practitioner specializing in dermatology at Werschler
Aesthetics, Spokane, Wash., “Dermatological diseases
often co-exist along with conditions such as major
depressive disorder, obsessive-compulsive disorder,
body dysmorphic disorder and a plethora of other
psychiatric illnesses.”
She notes that a recent study of 114 people with dermatological disorders showed that 39 — nearly 35% —
reported depression. By comparison, only about 7% of
adults in the U.S. general population report depression, according to National Institute of Mental Health
statistics.
“This isn’t surprising,” Dr. Werschler says. “How do
acne, alopecia areata, eczema, HSV breakouts, hyperhidrosis, lupus, melasma, nail fungus, pruritis, psoriasis, rosacea, scarring, skin cancer, sexually transmitted
diseases, urticaria, warts and don’t forget age-related
changes — how do they make any of us feel?”
She says there’s an extensive list of psychiatric diagnoses
dermatologists are likely see in combination with their patients’ dermatological condition. These disorders include
obsessive-compulsive, body dysmorphic, trichotillomania
“Dermatological diseases
often co-exist along with
conditions such as major
depressive disorder,
obsessive-compulsive
disorder, body dysmorphic
disorder and a plethora of
other psychiatric illnesses.”
Pamela Schell Werschler, Psy.D.
Spokane, Wash.
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
(hair-pulling), excoriation (picking at the
skin), substance/medication-induced
obsessive-compulsive behavior, avoidant/restrictive food intake, anorexia
nervosa, bulimia, binge eating, gender
dysphoria, generalized anxiety, posttraumatic stress disorder — the list goes
on and on.
symptoms of BDD in cosmetic settings. Scores of 40 or higher indicate
a BDD diagnosis. The scale can be repeated during treatment and used as
a measure of outcome. It is free to use
but should be cited if used.
CLINICAL DERMATOLOGY
“It’s important to treat the patient in a
holistic manner, including how they
may feel about their diagnosis,” Dr. Werschler says in summary. “And a crucial
part of doing this is to employ appropriate psychological assessment tools.” DT
ASSESSMENT TOOLS
The crux of the presentation was Dr.
Werschler’s discussion of the most useful psychological assessment tools. For
patients with depressive symptoms, she
recommends:
➧ The Beck Depression Inventory II
(BDI-II) (Beck, Steer, Ball, & Ranieri,
1996) — Appropriate for patients ages
13 to 80, it’s the most widely used clinically administered instrument for
the assessment of depression.
➧ BDI-Fast Screen for Medical Patients
(Beck, Steer, & Brown, 2000) — Contains just seven questions; also appropriate for patients ages 13 to 80.
➧ Hamilton Rating Scale for Depression-Rev ised (HAM-D) (Warren,
1994) — With 21 questions, it’s designed for adults and is used to rate
the severity of their depression by
probing mood, feelings of guilt, suicide ideation, insomnia, agitation or
retardation, anxiety, weight loss and
somatic symptoms.
➧ Children’s Depression Inventory-2
(CDI-2) (Kovacks, 2004) — Appropriate for ages seven to 17, the short version uses 12 questions, takes 5 to 10
minutes to administer and focuses on
emotional and functional symptoms.
PROCEDURE-SPECIFIC TOOLS
Dr. Werschler also recommends these
dermatologic- and cosmetic-procedurespecific assessment tools:
➧ Dermatolog y Life Qualit y Index
(DLQI) (Finlay & Kahn, 1992) — A selfreporting questionnaire frequently
used in research to assess the potential impact of dermatological disorders, medications and devices on patients’ quality of life.
➧ The Cosmetic Procedure Screening
Scale (COPS) (Veale et al., 2012) —
For the aesthetic provider, the most
concerning diagnosis is body dysmorphic disorder. COPS is a self-reporting scale designed to screen for
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43
44
COSMETIC
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
REJUVENATION DEVICES
47 FACIAL
Experts weigh in on their favorite
techniques and technologies
INGREDIENTS
57 CONTROVERSIAL
Downloadable patient data sheet may
help you steer the conversation
Three patterns of female hair loss
Medical management involves prolonging anagen phase, reversing matrix reduction
MEG BARBOR | STAFF CORRESPONDENT
Female pattern hair loss includes
three pathways of hair miniaturization based on the age of onset. Proper
medical management may slow thinning or, in some cases, regrow hair, according to research presented by Vera
Price, M.D., at the Annual Meeting of
the American Academy of Dermatology (San Francisco, Calif., 2015).
The three varieties of female hair
miniaturization, characterized by
shor ten i ng of t he a nagen phase
(shorter hair) and matrix reduction
(thinner hair), are androgenetic alopecia (AGA), female pattern hair loss
(FPHL) and senescent alopecia (SA).
“All three conditions result in miniaturization of the hair follicle without significant inf lammation, and
on biopsy all three conditions show
this. The clinical information (age of
onset) is needed to correctly diagnose
whether the biopsy represents SA,
AGA, or FPHL,” Dr. Price says. She is a
professor in the department of dermatology at the University of California,
San Francisco.
“All three conditions result in
miniaturization of the hair follicle
without significant inflammation, and on biopsy all three
conditions show this.”
Vera Price, M.D.
FEMALE HAIR LOSS see page 48
University of California, San Francisco
Quotable
ANDROGENETIC ALOPECIA
Androgenetic alopecia is characterized by common hereditary thinning
induced by androgens in genetically
susceptible women (and men). Onset
occurs after puberty, and by age 50 up
to 50% of women (and men) have been
affected by AGA.
All patients being evaluated for hair
loss should have a complete blood count
(CBC), thyroid-stimulating hormone
(TSH), ferritin, and vitamin D-25OH
checked. “It saves time if the patient can
bring these results to the first visit, and
any positive tests should be dealt with
appropriately,” Dr. Price says.
At the first visit, female patients
should also be checked for menstrual
irregularities, infertility, hirsutism,
severe cystic acne, galactorrhoea and
virilization. If any of these conditions
are present, then levels of testosterone (T), dehydroepiandrosterone sulfate (DHEAS) and prolactin should
be evaluated. If any of these levels are
DTExtra
“It is not a substitute for
a facelift, but it is painless, has no downtime
or side effects and can
provide 30% to 40% skin
tightening in all skin
types, safely.”
Min-Wei Christine Lee, M.D.
Walnut Creek, Calif.
On using Elixis in patients with mild to
moderate facial skin laxity
SEE STORY PAGE 47
A NEW WEBSITE LAUNCHED by
Israeli medical-device firm Lumenis
claims to provide information about
the latest energy-based skincare
treatments for common skin conditions
such as pigmentation, hair removal
and rejuvenation. AesthetiPedia is a
user-friendly, informative and patientoriented site that offers information on
the latest Lumenis device technologies.
Practitioners can refer patients to the site
to learn more about available treatments.
Read more:bit.ly/aesthetipedia
VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment
of Stage IA and IB mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) in patients
who have received prior skin-directed therapy
WHEN IT’S TIME TO MANAGE THE CHALLENGES OF STAGE IA AND IB MF-CTCL
VALCHLOR IS ON IT
The first and only FDA-approved topical formulation
of mechlorethamine (commonly known as nitrogen mustard)
Proven efficacy in a 12-month study 1
Once-daily gel (special handling and
disposal procedures should be followed)
Dependable formulation manufactured
with consistent quality and potency
Comprehensive resources provided by
VALCHLOR Support ™
For more information, including how to prescribe, visit www.valchlor.com
or call 1-855-4-VALCHLOR (1-855-482-5245).
DOSING AND APPLICATION
VALCHLOR is for topical dermatologic use only. Apply a thin film of gel once daily to affected areas of the skin. VALCHLOR is a
cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable
nitrile gloves when applying VALCHLOR. Patients and caregivers must wash hands thoroughly after handling or applying VALCHLOR.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions,
including anaphylaxis, have occurred with topical formulations of mechlorethamine.
WARNINGS AND PRECAUTIONS
Mucosal or eye injury: Exposure of mucous membranes to
mechlorethamine such as the oral mucosa or nasal mucosa
causes pain, redness, and ulceration, which may be severe.
Exposure of the eyes causes pain, burns, inflammation,
photophobia, and blurred vision. Blindness and severe
irreversible anterior eye injury may occur. Should eye
exposure or mucosal contact occur, immediately irrigate
for at least 15 minutes with copious amounts of water,
followed by immediate medical consultation
Secondary exposure: Avoid direct skin contact with
VALCHLOR in individuals other than the patients due to risk
of dermatitis, mucosal injury, and secondary cancers
Dermatitis: Dermatitis may be moderately severe or severe.
Monitor patients for redness, swelling, inflammation,
itchiness, blisters, ulceration, and secondary skin infections.
Stop treatment with VALCHLOR or reduce dose frequency
Non-melanoma skin cancer: Monitor patients during and
after treatment with VALCHLOR
Embryo-fetal toxicity: Women should avoid becoming
pregnant while using VALCHLOR due to the potential hazard
to the fetus. For nursing mothers, discontinue use of
VALCHLOR or nursing
Flammable gel: VALCHLOR is an alcohol-based gel. Avoid
fire, flame, and smoking until the gel has dried
ADVERSE REACTIONS
The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin
ulceration or blistering (6%), and skin hyperpigmentation (5%). These reactions may be moderately severe or severe.
Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension,
or discontinuation may be required.
To report SUSPECTED ADVERSE REACTIONS, contact Actelion Pharmaceuticals US, Inc., at 1-855-4-VALCHLOR
(1-855-482-5245) or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see Brief Summary of Prescribing Information
on adjacent page.
REFERENCE: 1. VALCHLOR [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; 2013.
VALCHLOR®and VALCHLOR Support™ are trademarks of Actelion Pharmaceuticals Ltd.
© 2014 Actelion Pharmaceuticals US, Inc. All rights reserved. VAL-00130 0814
A great idea finally gels
VALCHLOR® (mechlorethamine) gel, 0.016%
For Topical Dermatological Use Only
*#-01-++-,*5#.-/1#"721,#-20
"3#/0##!1'-,0
VALCHLOR
N=128
% of patients
ModeratelyAny Grade
Severe or Severe
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
This brief summary does not include all the information needed to use VALCHLOR safely and
effectively. See Full Prescribing Information for VALCHLOR.
6 VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB
mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior
skin-directed therapy.
6 The use of VALCHLOR is contraindicated in patients with known severe hypersensitivity
to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred
with topical formulations of mechlorethamine.
6 >> Mucosal or Eye Injury
Exposure of the eyes to mechlorethamine causes pain, burns, inflammation,
photophobia, and blurred vision. Blindness and severe irreversible anterior eye
injury may occur. Advise patients that if eye exposure occurs, (1) immediately
irrigate for at least 15 minutes with copious amounts of water, normal saline, or a
balanced salt ophthalmic irrigating solution and (2) obtain immediate medical care
(including ophthalmologic consultation).
Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes
pain, redness, and ulceration, which may be severe. Should mucosal contact
occur, immediately irrigate for at least 15 minutes with copious amounts of water,
followed by immediate medical consultation.
>> Secondary Exposure to VALCHLOR
Avoid direct skin contact with VALCHLOR in individuals other than the patient.
Risks of secondary exposure include dermatitis, mucosal injury, and secondary
cancers. Follow recommended application instructions to prevent secondary
exposure.
#/+1'1'0
The most common adverse reaction was dermatitis, which occurred in 56% of the
patients. Dermatitis was moderately severe or severe in 23% of patients. Monitor
patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and
secondary skin infections. The face, genitalia, anus, and intertriginous skin are at
increased risk of dermatitis. Follow dose modification instructions for dermatitis.
-,#*,-+)',,!#/
Four percent (4%, 11/255) of patients developed a non-melanoma skin cancer
during the clinical trial or during one year of post-treatment follow-up: 2%
(3/128) of patients receiving VALCHLOR and 6% (8/127) of patients receiving
the mechlorethamine ointment comparator. Some of these non-melanoma skin
cancers occurred in patients who had received prior therapies known to cause nonmelanoma skin cancer. Monitor patients for non-melanoma skin cancers during
and after treatment with VALCHLOR. Non-melanoma skin cancer may occur on
any area of the skin, including untreated areas.
+ /5-$#1*-4'!'15
Based on its mechanism of action, case reports in humans, and findings in
animals, VALCHLOR can cause fetal harm when administered to a pregnant
woman. There are case reports of children born with malformations in pregnant
women systemically administered mechlorethamine. Mechlorethamine was
teratogenic and embryo-lethal after a single subcutaneous administration to
animals. Advise women to avoid becoming pregnant while using VALCHLOR. If
this drug is used during pregnancy or if the patient becomes pregnant while taking
this drug, the patient should be apprised of the potential hazard to a fetus.
*++ *##*
Alcohol-based products, including VALCHLOR, are flammable. Follow
recommended application instructions.
6 In a randomized, observer-blinded, controlled trial, VALCHLOR 0.016% (equivalent to
0.02% mechlorethamine HCl) was compared to an Aquaphor®-based mechlorethamine
HCl 0.02% ointment (Comparator). The maximum duration of treatment was 12
months. Sixty-three percent (63%) of patients in the VALCHLOR arm and 67% in the
comparator arm completed 12 months of treatment.
Comparator
N=127
% of patients
ModeratelyAny Grade
Severe or Severe
Dermatitis
56
23
58
17
Pruritus
Bacterial skin infection
Skin ulceration or blistering
Skin hyperpigmentation
20
11
6
5
4
2
3
0
16
9
5
7
2
2
2
0
In the clinical trial, moderately-severe to severe skin-related adverse events were
managed with treatment reduction, suspension, or discontinuation. Discontinuations
due to adverse reactions occurred in 22% of patients treated with VALCHLOR and
18% of patients treated with the comparator. Sixty-seven percent (67%) of the
discontinuations for adverse reactions occurred within the first 90 days of treatment.
Temporary treatment suspension occurred in 34% of patients treated with VALCHLOR
and 20% of patients treated with the comparator. Reductions in dosing frequency
occurred in 23% of patients treated with VALCHLOR and 12% of patients treated with
the comparator.
Reductions in hemoglobin, neutrophil count, or platelet count occurred in 13% of
patients treated with VALCHLOR and 17% treated with Comparator.
6 No drug interaction studies have been performed with VALCHLOR. Systemic exposure
has not been observed with topical administration of VALCHLOR; therefore, systemic
drug interactions are not likely.
6 >> Pregnancy
/#%,,!51#%-/5
'0)2++/5
Mechlorethamine can cause fetal harm when administered to a pregnant woman.
There are case reports of children born with malformations to pregnant women
systemically administered mechlorethamine. Mechlorethamine was teratogenic
in animals after a single subcutaneous administration. If this drug is used during
pregnancy or if the patient becomes pregnant while taking this drug, the patient
should be apprised of the potential hazard to a fetus.
,'+*1
Mechlorethamine caused fetal malformations in the rat and ferret when given
as single subcutaneous injections of 1 mg/kg. Other findings in animals
included embryolethality and growth retardation when administered as a single
subcutaneous injection.
2/0',%-1&#/0
It is not known if mechlorethamine is excreted in human milk. Due to the potential
for topical or systemic exposure to VALCHLOR through exposure to the mother’s
skin, a decision should be made whether to discontinue nursing or the drug, taking
into account the importance of the drug to the mother.
#"'1/'!0#
Safety and effectiveness in pediatric patients have not been established.
#/'1/'!0#
A total of 79 patients age 65 and older (31% of the clinical trial population) were
treated with either VALCHLOR or the comparator in the clinical trial. Forty-four
percent (44%) of patients age 65 or older treated with VALCHLOR achieved a
Composite Assessment of Index Lesion Severity (CAILS) response compared to
66% of patients below the age of 65. Seventy percent (70%) of patients age 65 and
older experienced cutaneous adverse reactions and 38% discontinued treatment
due to adverse reactions, compared to 58% and 14% in patients below the age
of 65, respectively. Similar differences in discontinuation rates between age
subgroups were observed in the comparator group.
Manufactured for:
Actelion Pharmaceuticals US, Inc.
South San Francisco, CA 94080, USA
© 2014 Actelion Pharmaceuticals US, Inc. All rights reserved.
The body system associated with the most frequent adverse reactions was skin and
subcutaneous tissue disorders. The most common adverse reactions (occurring in at
least 5% of the patients) are shown in Table 1.
VAL-00133 0814
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
COSMETIC DERMATOLOGY
What’s new in facial rejuvenation
Experts weigh in on their favorite techniques and technologies
LISETTE HILTON | STAFF CORRESPONDENT
From single devices that perform a
spectrum of rejuvenation procedures,
to older devices that are re-emerging,
to new combinations using tried-andtrue technologies, dermatologists are
at the forefront of what’s new and exciting in facial rejuvenation. Two dermatologists weigh in with their favorites.
MICRONEEDLING
Tina S. Alster, M.D., director, Washington
Institute of Dermatologic Laser Surgery
and clinical professor of dermatology,
Georgetown University Hospital, Washington, DC, said she is a laser user and
abuser, but her top pick is no laser at all. It’s
micro-needling, which she says is affordable, and is an effective wrinkle reducer.
“I’m using microneedling every
day to minimize perioral rhytides
and large pores. I’m seeing impres-
tion, which will kickstart the woundhealing cascade,” Dr. Alster says. “Until
you see how these devices work in your
hands, keep the treatment confined
within cosmetic units. When treating
the perioral region, use the nasolabial
folds as your lateral border and treat
very lightly over the vermillion border.”
More experienced dermatologists
can venture beyond the cosmetic units,
without having to worry as much about
discoloration as with laser treatment.
When using microneedling on the
face to treat large pores, Dr. Alster
avoids the nasal bridge.
“The skin in that area is much thinner and more prone to bruising,” she
says.
COMBINATION APPROACH
Dr. Alster often combines microneedling to treat stubborn wrinkles on the
upper lip with light fractionated resur-
“Unlike lasers that produce heat during
treatment, the microneedling device
produces micro injuries in the skin
without heat; thereby, stimulating new
collagen production without
risk of postinflammatory
hyperpigmentation.”
Tina Alster, M.D.
Washington, DC
sive results—similar to those that are
achieved with fractionated laser treatment. Unlike lasers that produce heat
during treatment, the microneedling
device produces micro injuries in the
skin without heat; thereby, stimulating
new collagen production without risk
of postinflammatory hyperpigmentation,” Dr. Alster says.
Dr. Alster recommends that dermatologists who don’t have much or
any experience with microneedling
use it initially on small areas, such as
on patients’ upper lips, until they get
comfortable using the devices.
“You want to produce pinpoint
bleeding indicating dermal penetra-
facing on the rest of the face. For the
task, Dr. Alster says she uses the Clear
+ Brilliant (Solta Medical). Posttreatment healing is typically a couple of
days of skin redness.
“I instruct patients to ice the treatment areas for the remainder of the day
after the procedure. I recommend the
use of a soothing balm that contains
small amounts of hydrocortisone
under a medical barrier cream and a
non-chemical (physical) sunscreen.
Patients should apply the creams at
least four times a day for the first couple
of days after treatment,” she says.
Dr. Alster says she likes the Clear
+ Brilliant because, even though it’s
not as effective as the deeper lasers on
wrinkles and scars, it offers a relatively
easy postoperative recovery and it’s
less expensive for patients.
“It’s the one laser that my physician extenders perform. That being
the case, the patients save a little bit
of money and still get a very nice cosmetic outcome,” Dr. Alster says.
THREE LASERS IN ONE PLATFORM
Min-Wei Christine Lee, M.D., a dermatologist and cosmetic dermatologic surgeon who practices Walnut
Creek, Calif., spoke at
this year’s American
Academy of Dermatology (AAD) annual
meeting on Emerging
Lasers and Aesthetic
Technology. Dr. Lee’s
Min-Wei Christine favorite emerging techLee, M.D.
nologies for facial rejuvenation? The Fotona SP Dynamis
and Elixis.
Fotona SP Dynamis Pro (Fotona) is
based on an intraoral technology used
for years in dentistry. It was later discovered that what dentists were doing
to treat the inside of the mouth had a
skin tightening effect on the outer face.
Today, the combination intraoral and
outer laser procedure for skin rejuvenation is called Fotona 4D, using the
SP Dynamis Pro, according to Dr. Lee.
“Fotona SP Dynamis is like having
20 different lasers in a dermatology
practice, because it has so many different applications,” says Dr. Lee, who
helped develop the procedure and is
a consultant and researcher for the
company that makes it. “The reason it
can effectively perform so many different applications is because of [the
platform’s] longer pulse durations and
higher energy than other devices, as
well as the unique application of wavelengths.”
FOUR-STEP INTRAORAL PROCEDURE
Step 1: The intraoral procedure using
the Erbium PS03 smooth mode. This
is a unique nonablative fractional erbium with a long pulse duration of 250
milliseconds, according to Dr. Lee. The
FACIAL REJUVENATION see page 58
47
48
COSMETIC
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Extensive patchy alopecia
areata Photo: Vera Price, M.D.
Androgenetic alopecia in an 18-year-old girl
Photo: Vera Price, M.D.
FEMALE HAIR LOSS:
Treatment tips that improve patient satisfaction from page 44
abnormal, it does not mean the woman
is necessarily susceptible to AGA since
women with androgenetic alopecia
typically have normal values for all of
these tests. “But an abnormal test might
indicate how the doctor might proceed
to look for the cause of the hair loss,”
she says.
“The term ‘female pattern hair loss’
is gaining popularity as a less committal term when the role of androgens
is less clear-cut and other hormonal
and non-hormonal factors may play
a role,” Dr. Price says. Age of onset is
typically between the ages of 45 and
55 and is characterized by a change in
hair growth parameters pre- or postmenopause, but the pathogenetic
understanding of FPHL is incomplete.
SENESCENT ALOPECIA
Senescent alopecia (SA) is characterized
by age-related hair thinning in women
in their 60s, 70s and older, and is histologically similar to AGA, but differs in
hormonal activity and gene expression.
In AGA, hair growth cycle genes are
differentially expressed, whereas in
SA, systemic senescent/aging genes
are differentially expressed, suggesting that AGA and SA are two distinct
disorders.
MANAGING MINIATURIZATION
AGA, FPHL and SA all present different
mechanisms for a shared final pathway
of follicular downsizing or miniaturization. Medical management of these conditions involves methods of prolonging
the anagen phase and reversing matrix
reduction.
Minoxidil is appropriate for all three
conditions and works to stimulate hair
regrowth. The 2% solution should be
applied twice daily, and the 5% foam is
effective once daily. Both formulations
(solution and foam) should be applied directly to the scalp, not the hair, according
to Dr. Price.
“The 5% foam is slightly more effective
than the 2% solution, and is easy to apply
if the hair thinning is extensive, but more
difficult to apply when the thinning is
mild,” she notes.
Androgen blockage through the use of
5-alpha-reductase inhibitors (such as finasteride) can be used to retard thinning
in patients with AGA and can be safely
used in conjunction with minoxidil, but
does not stimulate regrowth on its own.
Finasteride is not effective in treating
SA, and is not recommended for use in
patients over the age of 60.
Androgen blockade has the potential
to feminize a male fetus, so the use of
oral contraceptives is essential during
the use of finasteride in women who are
or may become pregnant; an oral contraceptive that will not aggravate thinning (least androgenic) should be used
in conjunction with androgen blockage. The use of androgen receptor inhibitors
(anti-androgens) such as spironolactone
competitively blocks androgen receptors
and may retard thinning in patients with
AGA, but more evidence-based studies
are needed to show regrowth, she says.
Finally, estrogen, which acts indirectly
as an anti-androgenic agent, may retard
progression in women with AGA. This is
demonstrated in pregnant women with
AGA who often note an increase in hair
volume due to elevated estrogen levels.
However, there are currently no studies
demonstrating the use of estrogen for
hair regrowth.
“Medical management of female pattern hair loss requires agents that prolong anagen and reverse matrix reduction,” says Dr. Price. Further studies are
needed, but the use of minoxidil, androgen blockage, estrogen, or an approved
combination of these deliveries might
improve patient satisfaction associated
with female pattern hair loss. DT
Dr. Price has no relevant disclosures.
When first-line therapy is either inappropriate or
ineffective in managing mild-to-moderate eczema,
itc
HELP BREAK
THE ECZEMA
CYCLE
h
-Helps manage the progression of mild-to-moderate flares1
- Significantly reduces pruritus and clears the visible signs
and symptoms of eczema2*
- ELIDEL is available in 30g, 60g, and 100g tubes2
Not an actual
patient. Image for
representation only.
- ELIDEL is not indicated for use in children less than 2 years
of age or for long-term use (see Boxed Warning below)
ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic
treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older,
who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable.
ELIDEL Cream is not indicated for use in children less than 2 years of age.
WARNING:
Long-term Safety of Topical Calcineurin Inhibitors
Has Not Been Established.
Although a causal relationship has not been established,
rare cases of malignancy (e.g., skin and lymphoma) have
been reported in patients treated with topical calcineurin
inhibitors, including ELIDEL Cream.
Therefore:
@439/3:4:8143-9+72:8+4,945/)'1)'1)/3+:7/3/3./(/9478
including ELIDEL Cream, in any age group should be
avoided, and application limited to areas of involvement
with atopic dermatitis.
@7+'2/8349/3*/)'9+*,47:8+/3)./1*7+31+88
than 2 years of age.
IMPORTANT SAFETY INFORMATION
ELIDEL Cream is contraindicated in individuals with a history
of hypersensitivity to pimecrolimus or any of the components
of the cream.
Patients should be reevaluated by their healthcare provider
if signs and symptoms of atopic dermatitis do not improve
within 6 weeks. Treatment should be discontinued upon
resolution of signs and symptoms (e.g., itch, rash and
redness) for atopic dermatitis.
Before commencing treatment with ELIDEL Cream, bacterial
or viral infections at treatment sites should be resolved.
The most common adverse events seen in clinical studies
included application-site burning, headache, pharyngitis,
nasopharyngitis, cough, influenza, pyrexia, and viral infection.
The most common local adverse event seen in clinical studies
was application-site burning, which occurred in 8% to 26% of
patients treated with ELIDEL Cream. In clinical studies, skin
papillomas or warts were observed in 1% of ELIDEL patients.
If patients have lymphadenopathy that is unresolved or of
unclear etiology, discontinuation should be considered.
ELIDEL Cream should not be used with occlusive dressings.
ELIDEL Cream should not be applied to areas of active
cutaneous infections.
During the course of treatment, patients should minimize or
avoid natural or artificial sunlight exposure, even while ELIDEL
Cream is not on the skin. The potential effects of ELIDEL on
skin response to ultraviolet damage are unknown.
*In an investigator’s global assessment, 57% of Elidel-treated patients had mild-to-no pruritus vs 34% with vehicle; 35% of ELIDEL-treated patients were rated clear
or almost clear at Day 43 vs 18% with vehicle. Pooled results from two 6-week, randomized, double-blind, multicenter studies investigating the efficacy and safety
of ELIDEL in pediatric patients with predominantly moderate atopic dermatitis (n=403).
References: 1. Data on file, Valeant Pharmaceuticals North America LLC. 2. Elidel Cream Package Insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2010.
Please see Brief Summary of full Prescribing Information on following pages.
ELIDEL is a registered trademark of Meda Pharma S.A.R.L. and is used under
license by Valeant. Except as otherwise indicated, all product names, slogans
and other marks are trademarks of the Valeant family of companies.
© 2014 Valeant Pharmaceuticals North America LLC DM/ELD/14/0015
BRIEF SUMMARY (see package insert for Full Prescribing Information)
®
(pimecrolimus) Cream 1%
Elidel
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Rx Only.
See WARNINGS and boxed WARNING concerning long-term safety of topical
calcineurin inhibitors.
CONTRAINDICATIONS
ELIDEL (pimecrolimus) Cream 1% is contraindicated in individuals with a history of
hypersensitivity to pimecrolimus or any of the components of the cream.
WARNINGS
WARNING Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and
lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including
ELIDEL Cream.
Therefore:
G ;:@5:A;A?8;:3@1>9A?1;2@;<5/-8/-8/5:1A>5:5:45.5@;>?5:/8A05:3>1-95:
any age group should be avoided, and application limited to areas of involvement with
atopic dermatitis.
G >1-95?:;@5:05/-@102;>A?15:/4580>1:81??@4-:E1->?;2-31
Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal
studies and transplant patients following systemic administration has been associated
with an increased risk of infections, lymphomas, and skin malignancies. These risks are
associated with the intensity and duration of immunosuppression.
Based on this information and the mechanism of action, there is a concern about a potential
risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal
relationship has not been established, rare cases of skin malignancy and lymphoma have
been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.
Therefore:
G >1-9?4;A80:;@.1A?105:599A:;/;9<>;95?10-0A8@?-:0/4580>1:
G 2 ?53:? -:0 ?E9<@;9? ;2 -@;<5/ 01>9-@5@5? 0; :;@ 59<>;B1 C5@45: C117? <-@51:@?
should be re-examined by their healthcare provider and their diagnosis be confirmed
(see PRECAUTIONS).
G &41?-21@E;2>1-94-?:;@.11:[email protected]?410.1E;:0;:1E1->;2:;:/;:@5:A;A?
use. (See CLINICAL PHARMACOLOGY, WARNINGS, boxed WARNING, PRECAUTIONS,
INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)
PRECAUTIONS
General: The use of ELIDEL Cream should be avoided on malignant or pre-malignant skin
conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma
(CTCL), can present as dermatitis. ELIDEL Cream should not be used in patients with
Netherton’s Syndrome or other skin diseases where there is the potential for increased
systemic absorption of pimecrolimus. The safety of ELIDEL Cream has not been established
in patients with generalized erythroderma. The use of ELIDEL Cream may cause local
symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized
symptoms are most common during the first few days of ELIDEL Cream application and
typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS).
Bacterial and Viral Skin Infections: Before commencing treatment with ELIDEL Cream,
bacterial or viral infections at treatment sites should be resolved. Studies have not
evaluated the safety and efficacy of ELIDEL Cream in the treatment of clinically infected
atopic dermatitis. While patients with atopic dermatitis are predisposed to superficial
skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment
with ELIDEL Cream may be independently associated with an increased risk of varicella
zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema
herpeticum. In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed
in patients using ELIDEL Cream. The youngest patient was age 2 and the oldest was age 12.
In cases where there is worsening of skin papillomas or they do not respond to conventional
therapy, discontinuation of ELIDEL Cream should be considered until complete resolution of
the warts is achieved.
Patients with Lymphadenopathy: In clinical studies, 14/1,544 (0.9%) cases
of lymphadenopathy were reported while using ELIDEL Cream. These cases of
lymphadenopathy were usually related to infections and noted to resolve upon appropriate
antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known
to resolve. Patients who receive ELIDEL Cream and who develop lymphadenopathy should
have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology
for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL
Cream should be discontinued. Patients who develop lymphadenopathy should be monitored
to ensure that the lymphadenopathy resolves.
Sun Exposure: During the course of treatment, it is prudent for patients to minimize or avoid
natural or artificial sunlight exposure, even while ELIDEL is not on the skin. The potential
effects of ELIDEL Cream on skin response to ultraviolet damage are not known.
Immunocompromised Patients: The safety and efficacy of ELIDEL Cream in
immunocompromised patients have not been studied.
Information for Patients (See Medication Guide.)
Drug Interactions: Potential interactions between ELIDEL and other drugs, including
immunizations, have not been systematically evaluated. Due to low blood levels of
pimecrolimus detected in some patients after topical application, systemic drug interactions
are not expected, but cannot be ruled out. The concomitant administration of known CYP3A
family of inhibitors in patients with widespread and/or erythrodermic disease should be done
with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole,
fluconazole, calcium channel blockers and cimetidine.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year rat dermal
carcinogenicity study using ELIDEL Cream, a statistically significant increase in the
incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male
animals compared to vehicle and saline control male animals. Follicular cell adenoma of the
thyroid was noted in the dermal rat carcinogenicity study at the lowest dose of 2 mg/kg/day
[0.2% pimecrolimus cream; 1.5× the Maximum Recommended Human Dose (MRHD) based
on AUC comparisons]. No increase in the incidence of follicular cell adenoma of the thyroid
C-?:;@105:@41;>-8/->/5:;31:5/5@E?@A0E5:9-81>-@?A<@;
93730-EI $
based on AUC comparisons). However, oral studies may not reflect continuous exposure or
the same metabolic profile as by the dermal route.
In a mouse dermal carcinogenicity study using pimecrolimus in an ethanolic solution, no
increase in incidence of neoplasms was observed in the skin or other organs up to the highest
dose of 4 mg/kg/day (0.32% pimecrolimus in ethanol) 27x MRHD based on AUC comparisons.
However, lymphoproliferative changes (including lymphoma) were noted in a 13 week repeat
dose dermal toxicity study conducted in mice using pimecrolimus in an ethanolic solution
at a dose of 25 mg/kg/day (47x MRHD based on AUC comparisons). No lymphoproliferative
changes were noted in this study at a dose of 10 mg/kg/day (17x MRHD based on AUC
comparison). However, the latency time to lymphoma formation was shortened to 8 weeks
after dermal administration of pimecrolimus dissolved in ethanol at a dose of 100 mg/kg/day
(179-217x MRHD based on AUC comparisons).
In a mouse oral (gavage) carcinogenicity study, a statistically significant increase in the
incidence of lymphoma was noted in high dose male and female animals compared to vehicle
control male and female animals. Lymphomas were noted in the oral mouse carcinogenicity
study at a dose of 45 mg/kg/day (258-340x MRHD based on AUC comparisons). No drugrelated tumors were noted in the mouse oral carcinogenicity study at a dose of 15 mg/kg/day
D $.-?10;:'/;9<->5?;:?:-:;>-83-B-31>-@/->/5:;31:5/5@E?@A0E
a statistically significant increase in the incidence of benign thymoma was noted in 10
mg/kg/day pimecrolimus treated male and female animals compared to vehicle control
treated male and female animals. In addition, a significant increase in the incidence of
benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day
pimecrolimus treated male animals compared to vehicle control treated male animals.
No drug-related tumors were noted in the rat based on AUC comparisons) and at a dose of
5 mg/kg/day for female animals (21x MRHD based on AUC comparisons). In a 52-week dermal
photo-carcinogenicity study, the median time to onset of skin tumor formation was decreased
in hairless mice following chronic topical dosing with concurrent exposure to UV radiation
(40 weeks of treatment followed by 12 weeks of observation) with the ELIDEL Cream vehicle
alone. No additional effect on tumor development beyond the vehicle effect was noted with the
addition of the active ingredient, pimecrolimus, to the vehicle cream.
A 39-week oral monkey toxicology study was conducted with pimecrolimus doses of 15, 45
and 120 mg/kg/day. A dose dependent increase in expression of immunosuppressive-related
lymphoproliferative disorder (IRLD) associated with lymphocryptovirus (a monkey strain of
virus related to human Epstein Barr virus) was observed. IRLD in monkeys mirrors what
has been noted in human transplant patients after chronic systemic immunosuppressive
therapy, post transplantation lymphoproliferative disease (PTLD), after treatment with
chronic systemic immunosuppressive therapy. Both IRLD and PTLD can progress to
lymphoma, which is dependent on the dose and duration of systemic immunosuppressive
therapy. A dose dependent increase in opportunistic infections (a signal of systemic
immunosuppression) was also noted in this monkey study.
An oral fertility and embryofetal developmental study in rats revealed estrus cycle
disturbances, post-implantation loss and reduction in litter size at the 45 mg/kg/day dose
(38× MRHD based on AUC comparisons). No effect on fertility in female rats was noted at
10 mg/kg/day (12× MRHD based on AUC comparisons). No effect on fertility in male rats
was noted at 45 mg/kg/day (23× MRHD based on AUC comparisons), which was the highest
dose tested in this study (see full Prescribing Information for additional Carcinogenesis,
Mutagenesis and Impairment of Fertility data).
Pregnancy Teratogenic Effects
Pregnancy Category C: There are no adequate and well-controlled studies of topically
administered pimecrolimus in pregnant women. The experience with ELIDEL Cream when
used by pregnant women is too limited to permit assessment of the safety of its use
during pregnancy. Pimecrolimus was transferred across the placenta in oral rat and rabbit
embryofetal developmental studies. There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used only if clearly needed during pregnancy.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of
the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision
should be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother.
Pediatric Use: ELIDEL Cream is not indicated for use in children less than 2 years of age.
The long-term safety and effects of ELIDEL Cream on the developing immune system are
unknown (see WARNINGS, boxed WARNING, and INDICATIONS AND USAGE).
Three Phase 3 pediatric studies were conducted involving 1,114 patients 2-17 years of
-31&C;?@A051?C1>1C117>-:0;95F10B145/81/;:@>;8810?@A051?C5@4-C117;<1:
label phase and one was a vehicle-controlled (up to 1 year) safety study with the option for
?1=A1:@5-8@;<5/-8/;>@5/;?@1>;50A?1"2@41?1<-@51:@?C1>1E1->?;2-31:
the short-term studies, 11% of ELIDEL patients did not complete these studies and 1.5% of
ELIDEL patients discontinued due to adverse events. In the one-year study, 32% of ELIDEL
patients did not complete this study and 3% of ELIDEL patients discontinued due to adverse
events. Most discontinuations were due to unsatisfactory therapeutic effect.
The most common local adverse event in the short-term studies of ELIDEL Cream in pediatric
patients ages 2-17 was application site burning (10% vs. 13% vehicle); the incidence in the
long-term study was 9% ELIDEL vs. 7% vehicle (see ADVERSE REACTIONS). Adverse events
that were more frequent (>5%) in patients treated with ELIDEL Cream compared to vehicle
C1>141-0-/41
B?5:@41?4;>@@1>9@>5-8!-?;<4->E:35@5?B?
5:KA1:F-
(13% vs. 4%), pharyngitis (8% vs. 3%), viral infection (7% vs. 1%), pyrexia (13% vs. 5%),
/;A34
B?
-:041-0-/41B?
C1>15:/>1-?10;B1>B145/815:@41
E1->
safety study (see ADVERSE REACTIONS). In 843 patients ages 2-17 years treated with ELIDEL
Cream, 9 (0.8%) developed eczema herpeticum (5 on ELIDEL Cream alone and 4 on ELIDEL
Cream used in sequence with corticosteroids). In 211 patients on vehicle alone, there were no
cases of eczema herpeticum. The majority of adverse events were mild to moderate in severity.
Two Phase 3 studies were conducted involving 436 infants age 3 months-23 months. One
6-week randomized vehicle-controlled study with a 20-week open-label phase and one
safety study, up to one year, were conducted. In the 6-week study, 11% of ELIDEL and 48%
of vehicle patients did not complete this study; no patient in either group discontinued due
to adverse events. Infants on ELIDEL Cream had an increased incidence of some adverse
events compared to vehicle. In the 6-week vehicle-controlled study these adverse events
included pyrexia (32% vs. 13% vehicle), URI (24% vs. 14%), nasopharyngitis (15% vs. 8%),
gastroenteritis (7% vs. 3%), otitis media (4% vs. 0%), and diarrhea (8% vs. 0%). In the
open-label phase of the study, for infants who switched to ELIDEL Cream from vehicle, the
incidence of the above-cited adverse events approached or equaled the incidence of those
patients who remained on ELIDEL Cream. In the 6 month safety data, 16% of ELIDEL and
35% of vehicle patients discontinued early and 1.5% of ELIDEL and 0% of vehicle patients
discontinued due to adverse events. Infants on ELIDEL Cream had a greater incidence
of some adverse events as compared to vehicle. These included pyrexia (30% vs. 20%),
URI (21% vs. 17%), cough (15% vs. 9%), hypersensitivity (8% vs. 2%), teething (27% vs. 22%),
vomiting (9% vs. 4%), rhinitis (13% vs. 9%), viral rash (4% vs. 0%), rhinorrhea (4% vs. 0%),
and wheezing (4% vs. 0%).
Geriatric Use: Nine (9) patients ≥65 years old received ELIDEL Cream in Phase 3 studies.
Clinical studies of ELIDEL did not include sufficient numbers of patients aged 65 and over to
assess efficacy and safety.
ADVERSE REACTIONS
No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and
33 normal volunteers, respectively. In human dermal safety studies, ELIDEL (pimecrolimus)
Cream 1% did not induce contact sensitization or cumulative irritation.
In a one-year safety study in pediatric patients age 2-17 years old involving sequential
use of ELIDEL Cream and a topical corticosteroid, 43% of ELIDEL patients and 68% of
vehicle patients used corticosteroids during the study. Corticosteroids were used for
more than 7 days by 34% of ELIDEL patients and 54% of vehicle patients. An increased
incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and
urticaria were found in the patients that had used ELIDEL Cream and topical corticosteroid
sequentially as compared to ELIDEL Cream alone.
In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled
adult study, 843 and 328 patients respectively, were treated with ELIDEL Cream. In these
clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated
patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily
due to application site reactions, and cutaneous infections. The most common application
site reaction was application site burning, which occurred in 8%-26% of patients treated
with ELIDEL Cream.
The following table depicts the incidence of adverse events pooled across the 2 identically
designed 6-week studies with their open label extensions and the 1-year safety study for
pediatric patients ages 2-17. Data from the adult active-controlled study is also included in
this table. Adverse events are listed regardless of relationship to study drug.
Two cases of septic arthritis have been reported in infants less than one year of age in
clinical trials conducted with ELIDEL Cream (n = 2,443). Causality has not been established.
Treatment Emergent Adverse Events ( ≥1%)
Pediatric
Pediatric Patients*
Patients*
Vehicle-Controlled
Open-Label
(20
(6 Weeks)
(1 Year)
Weeks)
Elidel
Elidel
Elidel
Elidel
Elidel
Cream
Cream
Cream
Cream
Cream
(N=267) (N=136) (N=335) (N=272)
(N=75)
%
%
%
%
%
At Least 1 AE
68
71
72
85
75
Infections and Infestations
Upper Respiratory
14
13
19
5
8
Tract Infection NOS
Nasopharyngitis
10
7
20
27
21
Skin Infection NOS
3
5
5
2
4
Influenza
3
1
7
13
4
Ear Infection NOS
3
5
5
2
4
Otitis Media
2
1
3
3
5
Impetigo
2
2
4
4
5
Bacterial Infection
2
2
1
1
0
Folliculitis
1
1
1
2
4
Sinusitis
1
1
3
2
1
Pneumonia NOS
1
1
2
0
1
1
2
1
8
3
Pharyngitis NOS
Pharyngitis
1
2
3
0
<1
Streptococcal
Molluscum
1
0
1
2
0
Contagiosum
Staphylococcal
<1
4
2
0
<1
Infection
Bronchitis NOS
<1
2
1
11
8
Herpes Simplex
<1
0
1
3
3
Tonsillitis NOS
<1
0
1
6
0
Viral Infection NOS
1
1
<1
7
1
Gastroenteritis NOS
0
2
1
7
3
Chickenpox
1
0
1
3
4
Skin Papilloma
<1
0
1
3
<1
Tonsillitis Acute NOS
0
0
0
3
0
Pediatric Patients*
Vehicle-Controlled
*Ages 2-17 years
Adult Active
Comparator
(1 Year)
Elidel
Cream
(N=328)
%
78
4
8
6
10
6
1
2
2
6
1
<1
1
0
0
1
2
4
1
0
2
<1
0
0
Upper Respiratory Tract
<1
0
1
Infection Viral NOS
Herpes Simplex
0
0
<1
Dermatitis
Bronchitis Acute NOS
0
0
0
Eye Infection NOS
0
0
0
General Disorders and Administration Site Conditions
Application Site
10
13
2
Burning
Pyrexia
8
9
12
Application Site
3
5
2
Reaction NOS
Application Site
3
6
1
Irritation
Influenza Like Illness
<1
0
1
Application Site
<1
0
0
Erythema
Application Site
1
2
1
Pruritus
Respiratory, Thoracic and Mediastinal Disorders
Cough
12
8
9
Nasal Congestion
3
2
2
Rhinorrhea
2
1
1
Asthma Aggravated
2
2
4
Sinus Congestion
1
1
1
Rhinitis
<1
0
2
Wheezing
<1
1
1
Asthma NOS
1
1
3
Epistaxis
0
1
0
Dyspnea NOS
0
0
0
Gastrointestinal Disorders
Abdominal Pain Upper
4
4
3
Sore Throat
3
4
5
Vomiting NOS
3
4
4
Diarrhea NOS
1
1
1
Nausea
<1
2
1
Abdominal Pain NOS
<1
1
2
Toothache
<1
1
1
Constipation
<1
0
1
Loose Stools
0
1
1
Reproductive System and Breast Disorders
Dysmenorrhea
1
0
2
Eye Disorders
Conjunctivitis NEC
1
1
2
Skin and Subcutaneous Tissue Disorders
Urticaria
1
0
<1
Acne NOS
0
1
<1
Immune System Disorders
Hypersensitivity NOS
4
4
5
Injury and Poisoning
1
1
<1
Accident NOS
Laceration
1
1
2
Musculoskeletal, Connective Tissue and Bone Disorders
Back Pain
<1
2
<1
Arthralgias
0
0
<1
Ear and Labyrinth Disorders
Earache
1
1
0
Nervous System Disorders
Headache
14
9
11
2
0
<1
2
0
1
2
1
0
<1
0
<1
9
7
26
13
5
1
3
3
15
<1
4
6
2
3
2
2
0
2
2
0
6
16
2
<1
1
<1
4
1
4
3
2
11
1
1
1
<1
7
<1
3
1
1
2
1
0
0
1
2
0
2
<1
1
6
8
7
8
4
4
3
4
<1
7
5
8
5
7
4
1
<1
<1
<1
4
1
2
2
<1
1
0
0
1
1
1
2
4
3
<1
2
<1
<1
1
2
5
1
3
<1
<1
1
<1
0
0
<1
1
0
1
2
2
3
3
0
25
16
7
*Ages 2-17 years
POST-MARKETING EVENTS
The following adverse reactions have been reported in patients using ELIDEL Cream. Because
these reactions are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: Anaphylactic reactions, ocular irritation after application of the cream to the eye lids
or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol
use, skin discoloration
Hematology/Oncology: Lymphomas, basal cell carcinoma, malignant melanoma,
squamous cell carcinoma
OVERDOSAGE
There has been no experience of overdose with ELIDEL (pimecrolimus) Cream 1%. If oral
ingestion occurs, medical advice should be sought.
Manufactured by:
Novartis Pharma Produktions GmbH
Wehr, Germany
Distributed by:
Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ 08807
REV. 02/2014 (based on #2079799 06/11)
DM/ELD/14/0010(1)
52
COSMETIC
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
INGREDIENTS:
Human, animal studies not widely performed from page 1
human body,” Dr. Friedman says.
Fears surrounding parabens and
phthalates, for example, are derived
from cell line studies, he says. And to
compare the impact of these ingredients on a single cell type to the complexity of the human system—especially the skin, which is extraordinarily complex—is fuzzy math.
“A lot of what’s in the media about
these different ingredients, causing consumers to be so concerned, is
based on in vitro or cell-based assays,
rather than human studies, of which
there are very few,” Dr. Friedman says.
“A lot of what’s in the media about these
different ingredients...is based on in vitro
or cell-based assays, rather than
human studies, of which there
are very few.”
Adam Friedman, M.D.
Washington, D.C.
risk of breast cancer. Furthermore,
reported paraben exposure and tissue levels did not correlate with tumor
location, estrogen, or any attribute of
breast cancer, so it is difficult to say this
TAKE PARABENS, FOR EXAMPLE
is anything more than a hypothesis at
Do a Google search on parabens,
this point.”
which, according to the FDA, are the
Dr. Friedman says it’s easy for commost widely used preservatives in cospanies with an agenda to promote
metics and personal care products
paraben-free skin and hair care prodsuch as soap, shampoo, conditioner
ucts to twist the findings. But promotand moisturizers, and you’ll get a mix
ing parabens as cancer-causing is more
of educational and scary articles.
propaganda than truth, he says.
Parabens are preservatives that exWhile some consumer groups push
tend product shelf-life and prevent
for paraben-free products for genbacterial and fungal growth. Comeral safety, they admit there’s a lot we
mon parabens are methylparaben,
don’t know. The Environmental Workethylparaben, propylparaben and
ing Group (EWG) posted an article on
butylparaben.
its website, Cosmetics, Parabens,
It’s not always the product
and Cancer: What Are the
that’s unsafe, but rather
Facts? The lead paragraph
the way it’s used, acstates: “If you’re concording to one expert.
fused about the poten“Parabens are very
tial link between pararesources
that discuss
effective preservatives
bens and cancer, you’re
paraben
when used at the apnot alone. The ev isafety.
propriate levels — the
dence is inconclusive
levels that have the toxand professional opinbit.ly/parabenfallacies
icology data that shows
ions vary widely about
they are safe,” says Laura
whether there is, in fact, a
Goodman, M.S., senior scienconnection.”
tist, P&G Skin Care Scientific ComStill, consumer demand is fueling
munications.
the need for alternatives. Enter compaMuch of the concern comes from
nies like Made from Earth, which proresearch that found parabens within
duces and sells organic skin care prodsamples of breast cancer tumors.
ucts online.
“The hypothesis was these chemi“When we can, we don’t put [chemcals can act like estrogen in the body,
ical] preservatives in our products,”
and, because estrogen fuels certain
says Stergios Bekas, operations, Made
breast cancers, exposure could infrom Earth. “Vitamin E actually serves
crease tumor development and proas a good natural preservative. … neem
gression,” Dr. Friedman says. “That
oil is a great natural preservative and
sounds kind of linear and makes sense.
citric acid, which comes from citrus
However, these studies were unable to
fruit, is a great natural preservative,
show a causative role [or] demonstrate
as well.”
a conclusive connection between
But even these ingredients could be
paraben exposure and an increased
construed as harmful. Ingesting even
Facts
& Fallacies
small doses of neem oil, which is used
externally as a traditional medicine
in India, causes toxic effects, including seizures and renal failure, according to a Nov. 2013 paper in the Journal
of the Association of Physicians in India.1
In the cases where the natural preservatives wouldn’t prevent bacterial
growth, Made from Earth uses tetrasodium EDTA (ethylenediaminetetraacetic acid), which is a salt-based
preservative, according to Mr. Bekas.
“Our customers say, ‘Why do you use
a preservative when we want products to
be totally organic?’ There are some ingredients that if you don’t preserve them
bacteria will grow…. That’s just the way
it is. We would rather sell these products
because they’re great for you and preserve them in the right way, as opposed
to not preserve them and have them
grow harmful bacteria,” Mr. Bekas says.
Jacquelyn Levin, D.O., a dermatologist in Laguna Niguel, Calif., says personally she uses some products containing parabens as preservatives in
product formulations. Parabens, she
says, do a good job of preventing bacterial and microbial growth.
“… that is sort of the catch 22. Some
of the other preservatives out there
are a bit more difficult to formulate
with,” Dr. Levin says, adding that
we don’t know whether alternative
preservatives are safer than parabens.
“However, we have to respect that
many of our patients may be concerned with the risk of using products
with parabens and its good practice to
be able to offer alternatives,” she adds.
PHTHALATES
Phthalates are actually not preservatives. They’re meant to alter the feel
of products. Used predominately in
nail polishes, shampoos and soaps,
INGREDIENTS see page 54
PROVEN SOLUTIONS
FOR COMPROMISED SKIN
AVEENO® delivers proven solutions to nourish, soothe
and restore healthy skin and hair that meet our highest
standards for safety, efficacy and patient satisfaction.
AVEENO® Oat contains vital nutrients, fatty acids and
lipids naturally found in healthy skin. No single natural
ingredient has more clinical data and a longer history of
proven results for compromised skin.
Trusted by Dermatologists for over 60 years.
©Johnson & Johnson Consumer Companies, Inc. 2015
54
COSMETIC
DERMATOLOGY
DERMATOLOGY
®
SEPTEMBER 2015
2015 ⁄⁄ DERMATOLOGYTIMES
DERMATOLOGYTIMES.COM
.COM
INGREDIENTS:
Inactives not always what they seem from page 52
phthalates make materials more pliable, according to Dr. Friedman.
Some fea r t hat topic a l products containing phthalates can disrupt hormones and, if women use
phthalates when pregnant, it could
affect the fetus, Dr. Friedman says.
While the there’s not enough evidence to substantiate the claims,
according to the FDA, many manufacturers have eliminated phthalates.
INACTIVES NOT ALWAYS WHAT THEY SEEM
Ingredients in skin care aren’t always
what they seem, and a lot of science
goes into creating elegant formulations that are effective and safe. One
example: silicone.
“People hear the word silicone and
they immediately think that there’s
like a barrier that you’re putting on the
skin that doesn’t allow it to breathe….
That’s really not the case with silicone
technology today,” Ms. Goodman says.
Silicone used in some beauty products is a feel enhancer—it gives products a smooth, velvety feel.
P&G uses silicone molecules that
vary in size and are spherically shaped.
The shape of the molecules helps it roll
across the skin and fill different skin
textures and lines, better.
“The silicone that dermatologists
use to inject are very different than
what we use on a topical product,” Ms.
Goodman says.
The silicone ingredient is meant to
sit on top of the skin but can help deliver ingredients into the skin. Silicone
has been safely used in skin care products for some time, Ms. Goodman says.
But it’s important that manufacturers
that use silicone and other ingredients
purchase high-quality ingredients.
“We have very high quality standards. I can’t guarantee that every
manufacturer out there does that,”
Ms. Goodman says. “... we don’t use
ingredients that haven’t passed safety
and toxicology evaluations… and they
have to have published information on
them.”
An example of an inactive ingredient that benefits the skin, according to
Dr. Levin, would be ceramides, which
have been shown to be lacking not only
in mature skin but also in atopic skin.
“People with psoriasis are also
lacking certain ceramides,” Dr. Levin
says. “And what ceramides have been
shown to do is that they actually help
strengthen the skin and make it less
susceptible to irritation and also help
skin keep its own water and hydration
naturally. They’re included in moisturizers and cleansers.”
On the other side of the good-bad
spectrum, you have microbeads. Microbeads are a big topic—more because of the potential environmental
impact. They don’t dissolve, according to Ms. Goodman.
In response to that concern, P&G
has identified alternative technologies that are biodegradable.
P&G has begun to use sodium bicarbonate crystals to help scrub the skin.
“Sodium bicarbonate is baking soda
but it’s not the same form as the baking soda you have in your kitchen.
We have a crystalized form that actually dissolves as you use it. We
don’t want consumers to be over exfoliating; that’s one of the reasons it
dissolves, but then, also being that it
dissolves, it’s also biodegradable,” Ms.
Goodman says.
FRAGRANCES
Fragrances are considered to be trade
secrets, so their ingredients are mysteries to consumers, according to the
Campaign for Safe Cosmetics. Fragrances might contain allergens and
sensitizers, phthalates, neurotoxins
and synthetic musks, according to
SafeCosmetics.org.2
The potential concerns around
chemical fragrances are easy to address if patients are willing to use fragrance-free products. But consumers
like products with fragrance, according
to Diane Foster, a consultant who works
with leading skin care companies.
“A lot of times, companies are forced
to include fragrance, because when
they test the product, people come back
to them and say they want fragrances,”
Ms. Foster says. “However, good substantial, well-known companies have
a panel of [chemical] fragrances that
they have tested in the most sensitive
skin known to mankind and found
them not to be irritants.”
And some companies, including
Johnson & Johnson, are eliminating
At a glance
ingredient resources
} OTC
for physicians and patients
bit.ly/docsandpatients
product
} Prohibited
ingredients
bit.ly/prohibitedproducts
consumers
} What
are reading?
bit.ly/whatconsumersread
about preservatives
} Talking
with patients
bit.ly/patientsandparabens
and fallacies about
} Facts
paraben safety
bit.ly/parabenfactsfallacies
evidence around
} The
nanotechnology
bit.ly/evidencearoundnano
& Johnson’s
} Johnson
commitment to consumers
bit.ly/JohnsonJohnsoncommitment
perceived harmful ingredients in their
fragrances.
A not her option in fragrances:
essential oils, says Mr. Bekas.
“Essential oils come from the actual
fruit. We use a lot of citrus oils, like orange essential oils, grapefruit essential oils. They’re a lot more expensive
[because] they pretty much come from
crushing a bunch of oranges down and
making it a fine oil as opposed to a synthetic oil… that comes from the lab,”
Mr. Bekas says.
Mary P. Lupo, M.D., clinical professor of dermatology, Tulane University, New Orleans, La., says she prefers
products with natural oils, like lavender, for a light fragrance because those
give patients few problems.
But even natural fragrances are
INGREDIENTS see page 57
TREATING INFLAMMATORY LESIONS OF ROSACEA CAN BE TOUGH…
PRESCRIBE
A TOUGH
TOPICAL
SOOLANTRA® (ivermectin) CREAM, 1%—POWERFUL
AND RAPID RESULTS FROM A ONCE-DAILY TOPICAL1,2*†
. –20.5 (–64.9%) mean inflammatory lesion count reduction at week 122*†
. Better efficacy from once-daily Soolantra Cream, 1% vs twice-daily metronidazole 0.75% cream as early as 3 weeks3‡
. Specifically formulated for patients with inflammatory lesions of rosacea—Cetaphil® Moisturizing Cream was the basis for the vehicle2
w ww.s o o lant r a.c o m/hcp
Important Safety Information
Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Adverse Events: In clinical trials with SOOLANTRA® Cream,
the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation. Warnings/Precautions: Not for oral, ophthalmic, or intravaginal use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see brief summary of Prescribing Information on adjacent page.
* The efficacy and safety of SOOLANTRA® Cream, 1% once daily was evaluated in subjects aged ≥18 years in 2 identically designed phase 3 clinical trials (N=1371). Final results were comparable between the
2 studies, with the least favorable results presented here.
†
A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of SOOLANTRA® Cream, 1% once daily in 683 subjects with moderate to
severe papulopustular rosacea (Investigator Global Assessment [IGA] score of 3 or 4).
‡
An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA® Cream, 1% once daily with metronidazole 0.75% cream twice daily in 962 subjects with
moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.
IMPORTANT INFORMATION ABOUT
SOOLANTRA®
(ivermectin) Cream, 1%
BRIEF SUMMARY
This summary contains important information about
SOOLANTRA (soo lan’ trah) Cream. Read this information carefully
before you prescribe SOOLANTRA Cream. For full Prescribing
Information and Patient Information please see the package insert.
WHAT IS SOOLANTRA CREAM?
SOOLANTRA Cream is a topical prescription medicine indicated for the
treatment of the inflammatory lesions of rosacea.
WHO IS SOOLANTRA CREAM FOR?
SOOLANTRA Cream is indicated for people with inflammatory lesions
of rosacea. It is not known if SOOLANTRA Cream is safe and effective
for children. Advise your patients to not use SOOLANTRA Cream for a
condition for which it was not prescribed and remind them to not give
SOOLANTRA Cream to other people, even if they have the same symptoms
as it may harm them.
WHAT SHOULD I ASK MY PATIENTS BEFORE PRESCRIBING
SOOLANTRA CREAM?
Before you prescribe SOOLANTRA Cream, ask your patients if they:
SOOLANTRA Cream is supplied in a child-resistant capped tube.
>!223)1+)17/<35)66(2:1217,)',-/(5)6-67%17'%3%1(7:-67 '2817)5'/2'.:-6)!2%92-(63-//-1+(2127648))=)7,)78&):,-/)
opening or closing.
>!2'/26)+)17/<35)66(2:1217,)',-/(5)6-67%17'%3%1(7:-67 clockwise.
WHAT ARE THE INGREDIENTS IN SOOLANTRA CREAM?
Active ingredient: ivermectin. Inactive ingredients: carbomer copolymer
type B, cetyl alcohol, citric acid monohydrate, dimethicone, edetate
disodium, glycerin, isopropyl palmitate, methylparaben, oleyl alcohol,
phenoxyethanol, polyoxyl 20 cetostearyl ether, propylene glycol,
propylparaben, purified water, sodium hydroxide, sorbitan monostearate,
and stearyl alcohol.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT
SOOLANTRA CREAM?
>!,-65-)* 800%5<6800%5-=)67,)0267-03257%17-1*250%7-21
about SOOLANTRA Cream. For full Prescribing Information and
Patient Information please see the package insert.
>272www.soolantra.com or call 1-866-735-4137
>,%9)%1<27,)50)(-'%/'21(-7-216
>%5)35)+1%17253/%11-1+72&)'20)35)+1%177-6127.12:1-*
SOOLANTRA Cream can harm an unborn baby.
>%5)&5)%67*))(-1+253/%172&5)%67*))(7-6127.12:1-*
SOOLANTRA Cream passes into breast milk and if it can harm a baby.
Trademarks are the property of their respective owners.
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Revised: December 2014
WHAT ARE THE MOST COMMON SIDE EFFECTS OF
SOOLANTRA CREAM?
The most commonly reported side effects when using SOOLANTRA Cream
include skin burning sensation and skin irritation. Remind your patients to
tell you if they have any side effect that bothers them or that does not go
away. These are not all of the possible side effects of SOOLANTRA Cream.
For more information, see the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to
the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also
contact GALDERMA LABORATORIES, L.P. AT 1-866-735-4137.
HOW SHOULD PATIENTS USE SOOLANTRA CREAM?
> !5)%0-6*2586)217,)*%')21/<%1(6,28/(127&)86)(-1
the eyes, mouth, or vagina.
> !5)%06,28/(&)%33/-)(727,)%**)'7)(%5)%62*7,)*%')
once a day.
APPLYING SOOLANTRA CREAM:
>3)%6-=)(%028172* !5)%06,28/(&)%33/-)(72)%',
area of the face (forehead, chin, nose, each cheek) that is affected.
Avoid contact with the lips and eyes.
References: 1. Stein Gold L, Kircik L, Fowler J, et al; Ivermectin Phase III Study Group. Efficacy and safety of ivermectin 1% cream
in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs
Dermatol. 2014;13(3):316-323. 2. Data on file. Galderma Laboratories, L.P. 3. Taieb A, Ortonne JP, Ruzicka T, et al; Ivermectin
Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of
rosacea: a randomized, investigator-blinded trial. Br J Dermatol. 2015;172(4):1103-1110.
All trademarks are the property of their respective owners.
©2015 Galderma Laboratories, L.P.
Galderma Laboratories, L.P. 14501 N. Freeway, Fort Worth, TX 76177 SOL-255 Printed in USA 06/15
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Patient data sheet
download
http://bit.ly/Parabensforpatients
COSMETIC DERMATOLOGY
INGREDIENTS:
‘Natural’, ‘organic’ don’t mean ‘safe’ from page 54
not irritant-free. And the term “unscented” can be misleading, as a
masking fragrance might be used in
a product, according to Dr. Lupo.
“We tend to like to see ‘non-comedogenic,’ and ‘fragrance-free’ to help
guide our patients,” Dr. Lupo says.
ORGANIC...NATURAL...WHAT?
Use of the terms organic and natural
mean different things to different people and different cosmetic companies.
The FDA does not define or regulate
these terms.
“Having one natural ingredient
doesn’t make it a natural product,”
Ms. Foster says.
Dr. Lupo says “natural” does not
mean low allergenicity or more effectiveness.
“It simply means, in most cases,
that the active ingredient is found in
nature (a plant, usually),” she says.
It’s not so much what natural and
organic mean, but, rather, what they
imply. “There is this overall trend
that what’s good in your diet can easily be translated to skin care, and that
includes organic or natural skin care
lines, non-GMO, which stands for genetically modified, as well as gluten
free,” Dr. Friedman says.
The idea, he says, is that anything
that is synthetic is not good. But that
doesn’t make sense, according to Dr.
Friedman.
“Antioxidants, which most of these
skin care lines have, are highly unstable as well as have difficulty penetrating the skin. They need ingredients to
stabilize them and surfactants to help
them get to where they need to go. And
what about preserving them from bacterial contamination? Some skin care
lines that follow the paleo diet mentality are pretty much throwing chopped
fruit and proteins into a jar. That’s
not going to last more than a couple
of days before it gets colonized with
bacteria or fungi,” Dr. Friedman says.
The biology of the gastrointestinal tract is different than that of the
skin, Dr. Friedman says. Though the
cell types are somewhat similar, the,
architecture and immune environment
are different.
“While there is no question [there
is] a skin-gut connection with respect
Graphic courtesy of the Personal Care Products Council.
Sources: www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm128042.htm
to health, it’s really a poor comparison
when considering interactions with topically applied or ingested materials,” he
says.
That’s what makes the topical gluten-free fad curious, according to Dr.
Friedman.
In cosmetics, Triticum vulgare
(wheat) gluten can be found in mascaras
and skin and hair care products. Gluten functions as a binder or a hair and
skin conditioning agent. It may appear
as hydrolyzed wheat gluten, Triticum
vulgare (wheat) gluten, and Triticum
vulgare (wheat) gluten extract on the
label, all of which are huge wheat proteins. These can’t get through even an
impaired skin barrier. And there have
actually been studies in celiac patients
who used a shampoo with wheat gluten extract, according to Dr. Friedman.
“So unless the consumer is eating the
product, the likelihood of gluten sensitivity or inducing a flair of celiac disease
is next to none,” he says.
To assume natural and organic equal
safety in skin care is unfortunate, Dr.
Friedman says.
“There are toxic substances on the
planet that are ‘organic.’ Aflatoxin,
which is derived from fungi found on
peanuts, is the most carcinogenic material on the planet. Anthrax is organic. … bloodroot, an ingredient
found in online mole and skin tag removal creams is an extraordinary
escharotic agent. It burns right through
your skin like acid,” says Dr. Friedman,
who wrote a paper on the topic, published June 2012 in the Journal of Drugs
in Dermatology.
Poison ivy is natural, but people definitely don’t want to apply it to the skin,
Dr. Levin says. The dermatologist says
she tries to steer patients away from
products with tea tree oil.
“I know it has antimicrobial benefits
and it has a really nice cooling sensation on the skin, however there is a really high incidence of irritant in patients
that use tea tree oil,” Dr. Levin says. ”
TACKLING THE TOPIC (WITH PATIENTS)
Talking with patients about the safety of
controversial skin care ingredients can
be a long, losing battle, if patients who
are saturated with online information,
INGREDIENTS see page 58
57
58
COSMETIC
®
DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
INGREDIENTS:
Dermatologists need tools to help educate patients from page 57
according to Dr. Friedman.
“What would be useful is a centralized database or website, where a physician could easily download a factsheet
with the evidence laid out in plain English, and say these are the facts, these
are the studies…,” Dr. Friedman says.
“I think we as dermatologists need the
right tools because it’s a he-said, shesaid kind of conversation.”
Dr. Levin says she looks for OTC skin
and hair care companies that go the
extra mile and do studies showing that
the products are gentle or have extra
skin and hair benefits. These studies
should include studies on atopic skin or
even mature skin, she says, noting that
“There are many companies out there
that do that. Dove, for example, Cetaphil, CeraVe are companies that have
done that kind of work.”
Dermatologists, in general, should
feel at ease with having patients use researched products from credible, established companies, Dr. Friedman says.
“Beyond the risk for allergic contact
dermatitis, my feeling is [these ingredients] are safe,” Dr. Friedman says. DT
references online
bit.ly/otcingredients
FACIAL REJUVENATION:
Technique talk around various devices from page 47
intraoral laser can be used on the skin,
as well, she says.
“It can actually cause heating of
the oral mucosa without any injury or
burning,” Dr. Lee says. “This should
never be attempted with another erbium system because it would cause
severe burns.”
Step 2: When applied to the skin’s
surface, the Frac3 nonablative fractional Nd:YAG in the SP Dynamis
platform cleans debris from the pores,
helps to shrink the sebaceous glands,
kills propionibacterium acnes, or P.
acnes and makes skin smoother, according to Dr. Lee.
Step 3: The Piano mode Nd:YAG is
the only Nd:YAG laser on the market
that has long pulse durations of 6 seconds, which results in deep volumetric
bulk heating and skin tightening, according to Dr. Lee.
Step 4: This step involves an ablative erbium laser. The one that is part
of the Fotona SP Dynamis allows dermatologists the versatility of changing
settings—from light, superficial ablation to fully ablative with thermal coag.
Because of the ability to customize,
dermatologists can use the Fotona 4D
procedure on anybody, any skin type
and at any age, according to Dr. Lee.
She adds that there are no contraindications.
EXILIS FOR SKIN TIGHTENING, LIFTING
Exilis (BTL Aesthetics) is a focused,
continuous monopolar radiofrequency
(RF) device, which has face and body
applicators, according to Dr. Lee.
“It provides uniform volumetric
deep bulk heating (reaches a depth of
2.5 cm), resulting in skin tightening,”
she says.
Exilis has controlled contact cooling and real-time temperature monitoring, impedance intelligence and
energy flow control, which measures
impedance and temperature of the tissue and adjusts current accordingly,
according to Dr. Lee.
“This eliminates the chance of over
treatment, while providing uniform
energy delivery at optimal levels,” Dr.
Lee says. “RF energy is color blind,
making it safe for treating all skin
types.”
Researchers reported in September
2014 in the Journal of Drugs in Dermatology on 24 females who received two
treatments with bilateral monopolar
RF to the mid and lower face. Their assessments revealed a 35% reduction in
skin laxity, 42% reduction in fine lines
and wrinkles and 33% decreased appearance of photo damage. At three
months post-treatment, 92% of the
women showed at least mild skin laxity improvement. Ultrasound testing in
12 women showed a 19% improvement
in skin density, and histology showed
a notable increase in dermal collagen
and elastin fibers in two women. They
found no significant adverse events.1
The ideal Elixis candidate, according to Dr. Lee, is a patient who has mild
to moderate facial skin laxity.
“It is not a substitute for a facelift, but
it is painless, has no downtime or side
effects and can provide 30% to 40% skin
tightening in all skin types, safely,” she
says. “Patients with severe skin laxity
would not be good candidates. These
patients would not do well with any
laser procedure, they would require
surgery.”
An advantage of the Elixis, compared to Thermage (Valeant) and Ultherapy (Ulthera), is that it does not require expensive consumables, according to Dr. Lee.
Dr. Alster, however, who says she
used Elixis and offers Thermage and
other skin tighteners in her practice, favors Ulthera micro-focused ultrasound
for skin lifting and tightening.
“I routinely recommend Ulthera because I think it provides optimal noninvasive lifting due to its deep penetration and focused tissue effect. It can be
used alone to tighten the jawline and
lift the brow, but I often use it in conjunction with other treatments, including the Fraxel Clear + Brilliant and/or
microneedling in order to minimize
rhytides in the same treatment session,” Dr. Alster says. DT
Disclosures:
Dr. Lee has served as consultant and investigator
to: Lumenis, Cutera, Syneron, Iridex, Solta, Ulthera,
Cynosure, Fotona, BTL
Dr. Alster is a consultant to Merz.
References:
1. Mcdaniel D, Weiss R, Weiss M, Mazur C, Griffen
C. Two-treatment protocol for skin laxity using
90-Watt dynamic monopolar radiofrequency device with real-time impedance intelligence monitoring. J Drugs Dermatol. 2014;13(9):1112-7.
SMASH
AT THE SITE OF INFECTION1
*For the treatment of onychomycosis of the toenail(s) due to
Trichophyton rubrum and Trichophyton mentagrophytes.
NEW
LARGER
JUBLIA allows some patients to have clearer toenails grow back.
Individual results may vary.
INDICATION
JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical
treatment of onychomycosis (tinea unguium) of the toenail(s) due to
Trichophyton rubrum and Trichophyton mentagrophytes.
8
mL
size
Rx Only
IMPORTANT SAFETY INFORMATION
7 JUBLIA is for topical use only and is not for oral, ophthalmic, or intravaginal use.
7 Patients should be instructed to contact their health care professional if a reaction
suggesting sensitivity or severe irritation occurs.
7 The most common adverse reactions (incidence >1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%),
application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain
(1.1% vs 0.2%).
7 JUBLIA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus,
and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have
not been established.
Please see Brief Summary of full Prescribing Information on the adjacent page.
Reference: 1. JUBLIA [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2015.
Find out more by visiting www.JubliaRx.com.
®/TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.
Any other product or brand names and logos are the property of their respective owners.
© 2015 Valeant Pharmaceuticals North America LLC DM/JUB/15/0069(1)
*
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to use
JUBLIA safely and effectively. See full prescribing information for JUBLIA.
JUBLIA® (efinaconazole) topical solution, 10%
For topical use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated
for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton
rubrum and Trichophyton mentagrophytes.
DOSAGE AND ADMINISTRATION
Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated
flow-through brush applicator. When applying JUBLIA, ensure the toenail, the
toenail folds, toenail bed, hyponychium, and the undersurface of the toenail
plate, are completely covered.
JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.
CONTRAINDICATIONS
None.
ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect the
rates observed in practice.
In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least
24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of
treatment and in at least 1% of subjects treated with JUBLIA and those reported
in subjects treated with the vehicle are presented in Table 1.
Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated
for up to 48 Weeks
Adverse Event, n (%)
JUBLIA
N = 1227
Vehicle
N = 413
Ingrown toenail
28 (2.3%)
3 (0.7%)
Application site dermatitis
27 (2.2%)
1 (0.2%)
Application site vesicles
20 (1.6%)
0 (0.0%)
Application site pain
13 (1.1%)
1 (0.2%)
DRUG INTERACTIONS
In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither
inhibits nor induces cytochrome P450 (CYP450) enzymes.
Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered
during the period of organogenesis (gestational days 6-19) to pregnant female
rabbits. In the presence of maternal toxicity, there was no embryofetal toxicity or
malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).
In a pre- and post-natal development study in rats, subcutaneous doses of
1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of
organogenesis (gestation day 6) through the end of lactation (lactation day 20). In
the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup
mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at
25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD
based on AUC comparisons). No effects on postnatal development were noted at
25 mg/kg/day (89 times the MRHD based on AUC comparisons).
Nursing Mothers
It is not known whether efinaconazole is excreted in human milk. After repeated
subcutaneous administration, efinaconazole was detected in milk of nursing rats.
Because many drugs are excreted in human milk, caution should be exercised
when JUBLIA is administered to nursing women.
Pediatric Use
Safety and effectiveness of JUBLIA in pediatric subjects have not been established.
Geriatric Use
Of the total number of subjects in clinical trials of JUBLIA, 11.3% were
65 and over, while none were 75 and over. No overall differences in safety and
effectiveness were observed between these subjects and younger subjects, and
other reported clinical experience has not identified differences in responses
between the elderly and the younger subjects, but greater sensitivity of some
older individuals cannot be ruled out.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
A 2-year dermal carcinogenicity study in mice was conducted with daily topical
administration of 3%, 10% and 30% efinaconazole solution. Severe irritation was
noted at the treatment site in all dose groups, which was attributed to the vehicle
and confounded the interpretation of skin effects by efinaconazole. The high dose
group was terminated at week 34 due to severe skin reactions. No drug-related
neoplasms were noted at doses up to 10% efinaconazole solution (248 times the
MRHD based on AUC comparisons).
Efinaconazole revealed no evidence of mutagenic or clastogenic potential based
on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster
lung cell chromosome aberration assay) and one in vivo genotoxicity test (mouse
peripheral reticulocyte micronucleus assay).
No effects on fertility were observed in male and female rats that were
administered subcutaneous doses up to 25 mg/kg/day efinaconazole (279 times
the MRHD based on AUC comparisons) prior to and during early pregnancy.
Efinaconazole delayed the estrous cycle in females at 25 mg/kg/day but not at
5 mg/kg/day (56 times MRHD based on AUC comparisons).
PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information).
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies with JUBLIA in pregnant
women. JUBLIA should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Systemic embryofetal development studies were conducted in rats and
rabbits. Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were
administered during the period of organogenesis (gestational days 6-16) to
pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity
(increased embryofetal deaths, decreased number of live fetuses, and placental
effects) was noted at 50 mg/kg/day [559 times the Maximum Recommended
Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No
embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based
on AUC comparisons). No malformations were observed at 50 mg/kg/day
(559 times the MRHD based on AUC comparisons).
Manufactured for:
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
Manufactured by:
Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan
Product of Japan
U.S. Patents 8,039,494; 7,214,506
Based on 9391902
DM/JUB/15/0076 Issued: 02/2015
CUTANEOUS ONCOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
64 Strategies for drug resistance, combination
NMSC CHALLENGES
txs, adjuvant and post-op radiation
THERAPY
66 AT-HOME
Patient selection is critical;
compliance is key
Advances in treating NMSC
Hh inhibitors proving to be effective alternative to surgery, radiotherapy
LOUISE GAGNON | STAFF CORRESPONDENT
With medical treatment now available,
clinicians have less invasive therapies
to manage metastatic basal cell carcinoma (BCC) or locally advanced BCC.
“We now have medical therapy which
is quite effective,” says David Hogg, M.D.,
F.R.C.P.(C)., an attending physician at the
Princess Margaret Cancer Center in Toronto. “About 90% of basal cancers will
respond to the hedgehog inhibitor vismodegib (Erivedge, Genentech/Roche).
The drug is used for locally advanced
carcinoma and metastatic melanoma.”
Metastatic BCC has a median survival of eight to 14 months and a fiveyear survival rate of just 10%, and BCC
is regarded as incurable when it has
metastasized.
“BCC was strictly managed by surgeons or dermatologists,” Dr. Hogg says.
“Most of the time it is still managed
through surgery or dermatological excision. Other modalities used are cryo-
QUICK READ
Advances in research have led
to the emergence of medical
therapies for BCCs, and more
research is needed to develop
systemic therapies to treat SCCs.
therapy, freezing, or electrocautery.”
The five-year cure rate for modalities like surgical excision, curettage
and cautery, cryosurgery, and Mohs
micrographic surgery are very high at
95% and greater.
Previously, when surger y could
not be performed or when it would
result in a significant deformity, other
options such as radiotherapy, photodynamic therapy, chemotherapy, and
topical therapy would be considered,
according to Dr. Hogg. He is professor of medicine at the University of
Toronto in Toronto, Canada.
In some instances, he says, radiotherapy would be a less attractive option, in cases where the maximum safe
DTExtra
On July 24, 2015, The U.S. Food and Drug
Administration (FDA) approved sonidegib
(Odomzo) to treat patients with locally advanced
basal cell carcinoma after it has recurred following surgery or radiation therapy. Sonidegib
has also been approved for patients with locally
advanced basal cell carcinoma who are not candidates for surgery or radiation therapy. It is a once
daily oral that inhibits the Hedgehog pathway. This
agent may offer new hope for many patients who,
until now, have had very few treatment options.
dose of radiation to the region had been
reached, or when there was the risk of
organ damage (such as blindness).
HH SIGNALLING PATHWAY
Research has shown that abnormal activation of the Hedgehog signalling pathway is involved in the pathogenesis and
progression of all BCCs; in 90% of cases
this activation arises from mutations
of the Patched (PTCH) gene. Inhibitors
of the Hedgehog pathway typically result in dramatic tumor responses, with
shrinkage of the malignant tissue and
healing of ulcerative lesions.
Tumors that are very large and cannot be removed surgically or are located
near critical areas, such as around the
eye, are suitable for medical therapy
like vismodegib, Dr. Hogg explains.
“If they are near critical areas like the
face, the tumor may involve the eye or
cranial nerves, and can’t be dealt with
easily surgically,” he says.
ADVANCES see page 62
Quotable
There are four main
groups of patients who
warrant evaluation by a
multidisciplinary tumor
board and treatment
with adjuvant radiotherapy based on their
risk for recurrence.”
Jean Y. Tang, M.D., Ph.D.
Stanford University School of Medicine
OncoTherapy Network: bit.ly/sonidegibapproved
on radiotherapy to prevent relapse
SEE STORY PAGE 64
61
62
CUTANEOUS
®
ONCOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
ADVANCES:
Addressing side effects and drug resistance from page 61
Patients who are being considered
for medical therapy like vismodegib
will have their cases discussed by a
tumor board to discuss the suitability
of the therapy for the patient, explains
Dr. Hogg. When vismodegib therapy
is initiated, patients should be monitored regularly, being seen about every
28 days.
“The patients have to be managed
by a team including surgeons, radiation oncologists, medical oncologists,
and pathologists,” says Dr. Hogg.
Patients who have Gorlin syndrome,
a rare hereditary condition that predisposes individuals to develop multiple
BCCs, are good candidates for medical
therapy like vismodegib. Investigators
have observed that hand and foot pits,
which are pathognomonic signs of the
basal-cell nevus syndrome, were eliminated within a month of vismodegib
therapy.
BENEFITS, SIDE EFFECTS
A major benefit of vismodegib is that
most patients will respond to the therapy, but a disadvantage is that drug
resistance to the therapy does develop.
“It takes about 16 to 18 months
(for drug resistance to develop) in
locally advanced cases and about nine
months (for drug resistance to develop)
in metastatic cases,” Dr. Hogg notes.
Some of the toxicities associated with
vismodegib include hair loss, unpleasant taste in the mouth, and leg cramps,
Dr. Hogg says; but no dose-limiting or
grade 5 events have been observed with
vismodegib. Complete responses, however, are not often seen even in advanced
disease, and do not occur in metastatic
cases.
ALTERNATIVES TO AVOID
DRUG RESISTANCE
To address the issue of drug resis-
Epidemiology
of BCC
Louise Gagnon
BASAL CELL CARCINOMA (BCC) is the most common cancer in the world, with
about a third of individuals developing a BCC at one point in their lifetime, according to David Hogg, M.D., professor of medicine at the University of Toronto in Toronto, Canada.
The incidence is unfortunately increasing, with the overall incidence significantly
rising across the globe by about 3 to 10% annually1. Squamous cell carcinomas
represent about 20%, and BCCs represent 80% of non-melanoma skin cancers.
The development of BCC is strongly linked to exposure to ultraviolet radiation, with
the UV exposure resulting in cumulative DNA damage and gene mutations. The rising incidence of BCCs has also been attributed to increased longevity.
Interestingly, it has been observed that BCCs vary with geography: research suggests that the closer that Caucasians live to the equator, the greater the risk of developing BCCs2.
BCCs typically appear on sun-exposed sites like the face, scalp, ears, hands, and
trunk, with the majority appearing on the head and neck, Dr. Hogg says. In general, BCC incidence increases with rising socioeconomic class. However, patients
who develop complex, large or metastatic BCCs may have a lower socioeconomic
status and be more isolated socially than members of the general population3. DT
REFERENCES
1
Ruben AI, Chen EH, Ratner D. Basal-cell carcinoma. N Engl J Med. 2005;353(21):2262-29.
2
Diepen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002;146 Suppl 61:1-6.
3
Robinson JK, Altman JS, Rademaker AW. Socioeconomic status and attitudes of 51 patients with giant
basal and squamous cell carcinoma and paired controls. Arch Dermatol. 1995;131(4):428-31.
tance with vismodegib, investigators
have looked at alternative approaches
such as the use of the anti-fungal agent
itraconazole, which has shown anti-BCC
activity in animal models. A phase 2 study
where 19 patients received itraconazole,
and 10 patients vehicle, the active therapy
demonstrated activity in humans: administration of itraconazole decreased cellproliferation by 45%, Hedgehog pathway
activity by 65%, and tumor area by 24%1.
“It is still early days,” Dr. Hogg says.
“The other drug that has been flagged
is arsenic trioxide.”
Indeed, itraconazole and arsenic
trioxide (Trisenox, Cephalon) may be
useful in combination to overcome resistance to systemic treatment with
Hedgehog inhibitors like vismodegib.
Other emerging Hedgehog inhibitors
to treat locally advanced BCC or metastatic BCC include sonidegib, which was
recently approved by theFDA to treat advanced BCC after it has recurred following surgery or radiation therapy. Similar drugs are being explored in phase
1 studies to treat locally advanced and
metastatic BCC.
IN NEED OF BETTER SCC THERAPIES
Squamous cell carcinoma, a relatively common tumor, is usually managed by simple surgical excision, but
complex presentations of squamous
cell carcinoma do occur, which are
unresectable locally or metastatic disease, Dr. Hogg notes.
“We need better systemic treatment
for this disease,” says Dr. Hogg. “Many
patients (who have complex cases of
SCC) are old with co-morbid conditions
and many have immunosuppression.
They don’t tolerate chemotherapy very
well.”
Research into genetic targets is required to find better systemic treatments for complex presentations of SCC.
“The only target that has come up thus
far is the EGFR (epidermal growth factor receptor) pathway,” says Dr. Hogg.
Dr. Hogg sits on advisory boards for
BMS, Merck, Roche, and GSK. DT
1
Kim DJ, Kim J, Spaunhurst K, et al. Openlabel, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma.
J Clin Oncol. 2014;32(8):745-51.
Go to enstilarcomingsoon.com
LEO, the LEO Lion Design, and Enstilar are registered trademarks of LEO Pharma A/S.
Copyright 2015 LEO Pharma Inc. 3428-EN-15-314 March 2015 Printed in USA
64
CUTANEOUS
®
ONCOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Managing challenging NMSC cases
CHERYL GUTTMAN KRADER | STAFF CORRESPONDENT
QUICK READ
Most patients with non-melanoma
skin cancer (NMSC) can be successfully
treated with surgery alone, but not all. In
an educational session at the 2015 annual
meeting of the American Society of Clinical Oncology, speakers addressed management for some of the more challenging NMSC cases represented by patients
with advanced basal cell carcinoma (BCC)
and patients at high risk for recurrence.
Ongoing research is trying to identify
strategies for overcoming resistance
of advanced basal cell carcinoma to
targeted therapy with a Hedgehog
inhibitor. High level evidence to
support adjuvant radiotherapy
for high-risk non-melanoma skin
cancers is lacking, but certain
patients warrant evaluation by a
multidisciplinary tumor board and
treatment with adjuvant radiotherapy
based on their risk for recurrence.
BCC BASICS
BCC accounts for at least three-fourths
of cases of NMSC, and the determination
that it is primarily driven by a hyperactive Hedgehog (Hh) signaling pathway
was a landmark discovery as it opened
the door to targeted therapy, says Jean
Y. Tang, M.D., Ph.D., associate professor of dermatology, Stanford University School of Medicine, Stanford, CA.
In 2012, the FDA approved vismodegib (Erivedge, Genentech/Roche) as
the first targeted treatment for advanced
BCC (metastatic or non-operable).
However, once vismodegib was adopted in clinical practice and as more
patients were treated for longer periods
of time, it was realized that about 20%
of patients per year would develop resistance to the Hh inhibitor.
Now, findings from research undertaken by Dr. Tang and colleagues at
Stanford University suggest strategies
for overcoming the resistance.
Dr. Tang discussed the progress to date
in describing the mechanisms underlying BCC resistance to vismodegib, identifying potential interventions, and testing their efficacy in early clinical trials.
DRUG RESISTANCE INTERVENTIONS
“Advanced and metastatic BCC is quite
rare, but vismodegib represented an important advance for these challenging
cases and provided significant clinical benefit. As happens with most targeted oncologic therapies, however, some
BCCs developed resistance over time,”
Dr. Tang says.
Using genomic sequencing methods
to analyze samples from biopsies of resistant tumors, Dr. Tang and colleagues
were able to determine that about half
of the cases could be explained by reactivation of the Hh pathway second-
ary to mutations in Smoothened (SMO).
In an unbiased approach to screening led by Philip A. Beachy, Ph.D., professor of biochemistry, Stanford University, about 2,000 currently available
drugs were evaluated for their potential
to overcome resistance to vismodegib.
Through that work, itraconazole and
arsenic trioxide (Trisenox, Cephalon)
were identified as lead candidates.
“Advanced and
metastatic BCC
is quite rare,
but vismodegib
represented
an important
advance for these
challenging cases
and provided
significant
clinical benefit.”
Jean Y. Tang, M.D., Ph.D.
Stanford University School of Medicine
Like vismodegib, itraconazole inhibits SMO, but it binds to SMO at a different site than vismodegib. Arsenic trioxide, which is used for the treatment
of acute promyelocytic leukemia, acts
downstream of SMO in the Hh signaling pathway by binding the GLI transcription factor, she explains.
So far, a phase 2 clinical trial has been
completed investigating oral itraconazole in patients with BCC. The results
were encouraging as they showed significant reduction in cell proliferation,
Hh pathway activity, and tumor area.
Arsenic trioxide was evaluated in 5
patients using an intravenous regimen
with treatment given on 5 consecutive
days out of every 28 days. Disease stabilization was achieved in treated patients,
but there was no significant shrinkage
of tumor area with intermittent dosing.
“Next we will be evaluating daily
oral administration of arsenic trioxide based on the hypothesis that it may
be more effective with continuous dosing,” Dr. Tang says.
Research is also ongoing to try to identify the underlying mechanisms that
would explain the other 50% of cases of
vismodegib resistance and other strategies for overcoming resistance.
POTENTIAL IN COMBINATION THERAPIES
Evidence from studies using a mouse
model of medulloblastoma, another
tumor driven by the Hh signaling pathway, suggest a role for combination treatment with itraconazole and arsenic trioxide or using agents that inhibit both
SMO and PI3 kinase, Dr. Tang says.
To enable the research, Dr. Tang
would like to obtain tumor samples taken before and after treatment
initiation with vismodegib.
ADJUVANT RADIATION
TO PREVENT RELAPSE
Of the approximately 3.5 million new cases
of non-melanoma skin cancer (NMSC)
diagnosed each year in the United States,
about 5% are considered high risk for
local, regional, or distant recurrence.
High level evidence from prospectively collected data on the potential
benefits of adjuvant radiotherapy in
the postsurgical management of these
tumors is lacking. Nevertheless, based
on retrospective series, there appears
to be universal support for its use in patients with specific clinicopathologic
features, says Sandro V. Porceddu,
M.D., associate professor, The University of Queensland Australia, and senior radiation oncologist, Princess Alexandra Hospital, Brisbane.
“Due to the dearth of high-level
NMSC see page 70
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66
CUTANEOUS
®
ONCOLOGY
A
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
B
A. 43-year-old
female with SCC in
situ on left nasal
ala before and B. 1
month after second
round of red light
PDT (4 months
after first PDT); no
evidence of disease.
Photos: Anthony Rossi, M.D.
Compliance critical with at-home tx
JOHN JESITUS | STAFF CORRESPONDENT
The at-home regimens and close followup requirements of nonsurgical treatments
for skin cancer demand that dermatologists reserve these treatments for appropriate patients, according to an expert at
the American Academy of Dermatology
Annual Meeting (San Francisco, 2015).
With surgical treatment for skin cancers, Anthony M. Rossi, M.D., says “Once
you have negative margins, you know the
tumor is out.” He is an assistant attending physician in dermatologic, Mohs and
laser surgery at Memorial Sloan-Kettering Cancer Center.
“For melanoma,
pretreatment
mapping and
sampling
are the
keys.”
Anthony M. Rossi, M.D.
New York
With nonsurgical treatments, “The
key is picking the right patients beforehand. They must be compliant,” Dr. Rossi
says. Treatments that don’t allow one to
check margins microscopically require
close long-term follow-up for catching recurrences, he explains, and some nonsurgical skin cancer treatments require
at-home application as often as daily.
Among nonmelanoma skin cancers,
he says, “Not every basal cell carcinoma
(BCC) is created equal.” He usually tries
nonsurgical treatments on superficial
and early nodular BCCs.
QUICK READ
Due to the complexities and followup requirements of nonsurgical
treatments for skin cancer, patient
selection is critical. Expert offers tips
for using various noninvasive treatment
options for BCC, SCC, and melanoma.
PRACTICAL PRESCRIBING TIPS: IMIQUIMOD
Imiquimod is Food and Drug Administration-approved for superficial BCC; using
it for early nodular BCCs is off-label. Dr.
Rossi also prescribes it off-label for squamous cell carcinomas (SCCs).
In counseling patients, he outlines
cure rates of all BCC treatments. These
range from 97% to 98% for Mohs surgery
(primary tumors at 5 years), to 61% for
cryosurgery (at 2 years).
Studies involving imiquimod for early
nodular BCC show 5-year cure rates between 82% and 73%.1 However, he quotes
patients a 5-year cure rate of roughly 70%
for imiquimod overall.
With imiquimod, Dr. Rossi favors a
step-wise approach, starting every other
day, then five days weekly, and finally
daily, as tolerated. “I basically titrate it
up” until patients experience a stable reaction, which includes a level of erythema
and crusting they can accept. “If that happens at 5 days a week, then I keep them
there. But if they’re not getting a reaction,
I step it up to 7 days a week.” Even at that
level, he says, some patients don’t respond, so he switches them to other treatments or adds a topical retinoid. “However, even if they do get a reaction, that
doesn’t always mean it’s working. They
still have to follow-up” to make sure.
With imiquimod, “I always stress that
it has to do with patient compliance and
how people react. Some patients will use
imiquimod diligently even if they get a
lot of crusting and redness. Others will
stop and not tolerate the effects.”
Patients typically apply a 25 cm² dose.
“I usually prescribe it for 8 to 12 weeks,
based on the studies.” For small treatment
areas, “I usually wait until the skin heals,
then rebiopsy, if I see anything clinically,”
to make sure the tumor is cleared.
Dr. Rossi also uses imiquimod for adjuvant therapy of BCCs and SCCs incompletely cleared with Mohs surgery in cases
where achieving complete clearance of
superficial disease may not be possible,
or there is a large actinic field effect.
Very small studies of adjuvant therapy
with imiquimod have yielded mixed results, he says. “The cases where I find imiquimod does not work are usually those
with a more aggressive histological subtype such as infiltrative BCC.”
For SCC in situ, Dr. Rossi uses 5-fluorouracil (off-label), titrating up to daily use,
if tolerated, as with imiquimod. Patients
typically require 2 4-week cycles, he says.
PHOTODYNAMIC THERAPY PEARLS
Before using PDT for BCC or SCC, Dr. Rossi
typically prepares the skin with acetone
or a fractional CO2 laser at a superficial
setting to attempt to remove the stratum
corneum.
“I’m trying to create better absorption of the aminolevulinic acid. I still
do a traditional 3-hour incubation,
with occlusion, because you want to
get as much absorption as possible by
the skin cancer,” Dr. Rossi explains.
Giving the patient antihistamines
(preferably nonsedating) pre-procedurally can help minimize post-treatment
swelling, he adds. “Then I use blue light
COMPLIANCE see page 69
ACZONE® (dapsone) Gel 5%
BRIEF SUMMARY—PLEASE SEE THE ACZONE® PACKAGE INSERT FOR FULL
PRESCRIBING INFORMATION.
INDICATIONS AND USAGE
ACZONE® Gel, 5%, is indicated for the topical treatment of acne vulgaris.
DOSAGE AND ADMINISTRATION
For topical use only. Not for oral, ophthalmic, or intravaginal use. After the
skin is gently washed and patted dry, apply approximately a pea-sized
amount of ACZONE® Gel, 5%, in a thin layer to the acne affected areas
twice daily. Rub in ACZONE® Gel, 5%, gently and completely. ACZONE®
Gel, 5%, is gritty with visible drug substance particles. Wash hands after
application of ACZONE® Gel, 5%.
If there is no improvement after 12 weeks, treatment with ACZONE® Gel,
5%, should be reassessed.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Hematological Effects
Oral dapsone treatment has produced dose-related hemolysis and
hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase
(G6PD) deficiency are more prone to hemolysis with the use of certain
drugs. G6PD deficiency is most prevalent in populations of African, South
Asian, Middle Eastern, and Mediterranean ancestry.
There was no evidence of clinically relevant hemolysis or anemia in
patients treated with ACZONE® Gel, 5%, including patients who were
G6PD deficient. Some subjects with G6PD deficiency using ACZONE®
Gel developed laboratory changes suggestive of mild hemolysis.
If signs and symptoms suggestive of hemolytic anemia occur, ACZONE®
Gel, 5% should be discontinued. ACZONE® Gel, 5% should not be
used in patients who are taking oral dapsone or antimalarial medications
because of the potential for hemolytic reactions. Combination of
ACZONE® Gel, 5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may
increase the likelihood of hemolysis in patients with G6PD deficiency.
Peripheral Neuropathy
Peripheral neuropathy (motor loss and muscle weakness) has been
reported with oral dapsone treatment. No events of peripheral neuropathy
were observed in clinical trials with topical ACZONE® Gel, 5% treatment.
Skin
Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis,
erythema nodosum, and urticaria) have been reported with oral dapsone
treatment. These types of skin reactions were not observed in clinical
trials with topical ACZONE® Gel, 5% treatment.
ADVERSE REACTIONS
Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may
not reflect the rates observed in practice.
Serious adverse reactions reported in patients treated with ACZONE®
Gel, 5%, during clinical trials included but were not limited to
the following:
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In the clinical trials, a total of 12 out of 4032 patients were reported to
have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with
ACZONE® Gel, 5%). Psychosis was reported in 2 of 2372 patients treated
with ACZONE® Gel, 5%, and in 0 of 1660 patients treated with vehicle.
Combined contact sensitization/irritation studies with ACZONE®
Gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with
moderate erythema. ACZONE® Gel, 5%, did not induce phototoxicity or
photoallergy in human dermal safety studies.
ACZONE® Gel, 5%, was evaluated for 12 weeks in four controlled studies
for local cutaneous events in 1819 patients. The most common events
reported from these studies include oiliness/peeling, dryness, and erythema.
One patient treated with ACZONE® Gel in the clinical trials had facial
swelling which led to discontinuation of medication.
In addition, 486 patients were evaluated in a 12 month safety study. The
adverse event profile in this study was consistent with that observed in the
vehicle-controlled studies.
Experience with Oral Use of Dapsone
Although not observed in the clinical trials with ACZONE® Gel (topical
dapsone) serious adverse reactions have been reported with oral use of
dapsone, including agranulocytosis, hemolytic anemia, peripheral neuropathy
(motor loss and muscle weakness), and skin reactions (toxic epidermal
necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions,
bullous and exfoliative dermatitis, erythema nodosum, and urticaria).
DRUG INTERACTIONS
Trimethoprim-Sulfamethoxazole
A drug-drug interaction study evaluated the effect of the use of ACZONE®
Gel, 5%, in combination with double strength (160 mg/800 mg)
trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration,
systemic levels of TMP and SMX were essentially unchanged. However,
levels of dapsone and its metabolites increased in the presence of TMP/
SMX. Systemic exposure (AUC0-12) of dapsone and N-acetyl-dapsone
(NAD) were increased by about 40% and 20% respectively in the
presence of TMP/SMX. Notably, systemic exposure (AUC0-12) of dapsone
hydroxylamine (DHA) was more than doubled in the presence of TMP/
SMX. Exposure from the proposed topical dose is about 1% of that from
the 100 mg oral dose, even when co-administered with TMP/SMX.
Topical Benzoyl Peroxide
Topical application of ACZONE® Gel followed by benzoyl peroxide in
subjects with acne vulgaris resulted in a temporary local yellow or orange
discoloration of the skin and facial hair (reported by 7 out of 95 subjects
in a clinical study) with resolution in 4 to 57 days.
Drug Interactions with Oral Dapsone
Certain concomitant medications (such as rifampin, anticonvulsants,
St. John’s wort) may increase the formation of dapsone hydroxylamine,
a metabolite of dapsone associated with hemolysis. With oral dapsone
treatment, folic acid antagonists such as pyrimethamine have been noted
to possibly increase the likelihood of hematologic reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects: Pregnancy Category C
There are no adequate and well controlled studies in pregnant women.
Dapsone has been shown to have an embryocidal effect in rats and rabbits
when administered orally in doses of 75 mg/kg/day and 150 mg/kg/day
(approximately 800 and 500 times the systemic exposure observed in
human females as a result of use of the maximum recommended topical
dose, based on AUC comparisons), respectively. These effects were
probably secondary to maternal toxicity. ACZONE® Gel, 5%, should be
used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Nursing Mothers
Although systemic absorption of dapsone following topical application of
ACZONE® Gel, 5%, is minimal relative to oral dapsone administration, it is
known that dapsone is excreted in human milk. Because of the potential for
oral dapsone to cause adverse reactions in nursing infants, a decision should
be made whether to discontinue nursing or to discontinue ACZONE® Gel,
5%, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and efficacy was evaluated in 1169 children aged 12-17 years
old treated with ACZONE® Gel, 5%, in the clinical studies. The adverse
event rate for ACZONE® Gel, 5%, was similar to the vehicle control group.
Safety and efficacy was not studied in pediatric patients less than 12 years
of age, therefore ACZONE® Gel, 5%, is not recommended for use in this
age group.
Geriatric Use
Clinical studies of ACZONE® Gel, 5%, did not include sufficient number of
patients aged 65 and over to determine whether they respond differently
from younger patients.
G6PD Deficiency
ACZONE® Gel, 5% and vehicle were evaluated in a randomized,
double-blind, cross-over design clinical study of 64 patients with G6PD
deficiency and acne vulgaris. Subjects were Black (88%), Asian (6%),
Hispanic (2%) or of other racial origin (5%). Blood samples were taken
at Baseline, Week 2, and Week 12 during both vehicle and ACZONE®
Gel, 5% treatment periods. There were 56 out of 64 subjects who had a
Week 2 blood draw and applied at least 50% of treatment applications.
ACZONE® Gel was associated with a 0.32 g/dL drop in hemoglobin
after two weeks of treatment, but hemoglobin levels generally returned
to baseline levels at Week 12.
There were no changes from baseline in haptoglobin or lactate dehydrogenase during ACZONE® or vehicle treatment at either the 2-week or
12-week time point.
The proportion of subjects who experienced decreases in hemoglobin
≥1 g/dL was similar between ACZONE® Gel, 5% and vehicle treatment (8
of 58 subjects had such decreases during ACZONE® treatment compared
to 7 of 56 subjects during vehicle treatment among subjects with at
least one on-treatment hemoglobin assessment). Subgroups based on
gender, race, or G6PD enzyme activity did not display any differences in
laboratory results from the overall study group. There was no evidence of
clinically significant hemolytic anemia in this study. Some of these subjects
developed laboratory changes suggestive of mild hemolysis.
OVERDOSAGE
ACZONE® Gel, 5%, is not for oral use. If oral ingestion occurs,
medical advice should be sought.
Rx ONLY
© 2014 Allergan, Inc.
Irvine, CA 92612, U.S.A.
®
marks owned by Allergan, Inc.
Patented. See www.allergan.com/products/patent_notices
Based on 72205US13
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SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
CUTANEOUS ONCOLOGY
COMPLIANCE:
Patient selection key to therapy considerations from page 66
for more superficial BCCs or SCCs.”
For deeper nodular BCCs or slightly
thicker SCCs, Dr. Rossi uses red light. Additional light sources that have been used
for PDT in skin cancer include pulsed dye
lasers and intense pulsed light.
In solid organ transplant recipients
(SOTRs), studies have shown that cyclical PDT performed every couple months
reduces precancers and skin cancers.2
“Now I offer it as a treatment to clear actinic damage for my SOTR patients who
are on immunosuppression.”
For keratoacanthomas (quickly erupting SCCs), “I use injectable methotrexate
(typically 1cc total, injected in 4 quadrants at the lesion’s base) to either shrink
the keratoacanthoma to possibly make
the Mohs surgery smaller, or to treat it
definitively without doing Mohs afterwards,” he says. “We know that some keratoacanthomas will respond completely
to methotrexate, while others may not, so
close follow-up is needed to assess for residual disease or a more aggressive SCC.”
Patients typically require 2 to 3 sessions
total, spaced 2 to 3 weeks apart, he says.
RADIATION PATIENT SELECTION
Radiation offers a higher cure rate for
BCC than SCC.3,4 Dr. Rossi typically reserves this treatment for patients with
BCC or SCC who reject surgery or are
not candidates for topical treatment or
PDT. Patients for whom he typically does
not use radiation include the following:
➧ Those under age 55 because radiation can increase the risk of future skin
cancers, he explains.
➧ Patients with basal cell nevus syndrome
or other conditions that predispose them
to radiation-induced skin cancers.
➧ Those with BCCs on poorly healingareas, such as the legs or dorsal hand.
Additionally, “If the tumor is very
deep, radiation can cause a breakdown
of the cartilage or bone. And with verrucous carcinoma (an SCC subtype),
we don’t want to irradiate because
there’s a documented increase in metastases after radiation.”5
ORAL THERAPY CONSIDERATIONS
Typically, Dr. Rossi reserves the oral
smoothened (Smo) inhibitor vismodegib
for advanced and metastatic BCCs, which
are rare. Similarly, “For some advanced
patients in whom radiation would be con-
traindicated, or if the tumor is so large
that it would cause significant cosmetic
deformity and postsurgical morbidity,
vismodegib is now an option.” However,
he says, more research is needed to determine appropriate vismodegib uses
beyond its labeled indication.
In one study, 30% of patients with metastatic BCC and 43% of patients with locally advanced BCC experienced at least
30% reductions in tumor size. Median
duration of response was 7.6 months.6
Currently, Dr. Rossi says, researchers
are experimenting with drug “holidays”
to reduce side effects — mainly hair
loss, muscle cramps and taste changes.
“Some people can live with those side
effects; other people cannot.” Some patients experience tumor regrowth after
stopping the medication, he adds, so follow-up is crucial here as well.
For basal cell tumors with squamous
cell features (basal-squamous differentiation), Dr. Rossi says, “Vismodegib
might not be so helpful. Although it
may treat the basal-cell part, the squamous-cell part may still be growing.”
In cases where it’s unclear whether a
tumor is purely BCC or otherwise, he
recommends extra biopsies to sample
the tumor thoroughly.
“The key is picking
the right patients
beforehand.
They must be
compliant.”
Anthony M. Rossi, M.D.
New York
MELANOMA TX RECOMMENDATIONS
“For melanoma, pretreatment mapping
and sampling are the keys. So I often do
pretreatment mapping biopsies (along
the periphery of the lesion) to try to gauge
where the melanoma is. Melanomas can
have not only subclinical extension horizontally, but they can also have occult
invasion.” In his research, Dr. Rossi also
uses confocal microscopy, with or without biopsies, for suspected melanomas,
BCCs and SCCs. “Confocal microscopy
helps me to map out the lesion better, to
hone in on where we’re going to treat,
and look for recurrences or invasion.”
For biopsy-confirmed melanoma in
situ (MIS), Dr. Rossi offers imiquimod
and, in rare cases, radiation. “With imiquimod, the treatment is longer than
for BCC or SCC. I usually say at least
12 weeks. Some patients have gone up
to 20 weeks. It really depends on how
consistently patients use it and what results they’re getting. We want to see that
they’re getting redness, crusting and
some skin breakdown. But again, when
this was studied, these treatment effects
did not correlate with clinical success.”7
In one recent study of 347 patients,
histologic clearance rate was 76.2% and
the clinical clearance rate was 78.3%. The incidence of clinical recurrence was
2.3% at a mean follow-up of 34.2 months. After statistical analysis, treatment with
greater than 60 total imiquimod applications was associated with an odds ratio of
8.4 for histological clearance. Also, treatment with greater than 5 applications per
week was associated with an odds ratio
of 6.0 for histological clearance.8
For patients with invasive melanoma
that has a wide MIS on its periphery,
“Sometimes I will do surgery to debulk
the invasive melanoma, if patients can’t
undergo the full surgery. Then I prescribe imiquimod for the surrounding
area postsurgery, or for incomplete margins. These patients must be followed up
regularly because we know melanoma
may not recur within the first year. It may
take longer. I use confocal microscopy,
dermatoscopy and close clinical followup to monitor for any signs of recurrence
or invasion.”
Finally, he uses radiation as a noninvasive treatment for melanoma in patients who cannot undergo surgery or
fail imiquimod. Because melanoma
can have subclinical extension, “You
must have a wider field. Some advocate at least a 1 cm margin around the
whole lesion depending on anatomical
location.” Here too, strong follow-up is
essential. In one study, “The mean time
to recurrence was about 45 months.”9 DT
Disclosures: Dr. Rossi is an advisory board
member for Novartis.
For references : bit.ly/At-hometx
69
70
CUTANEOUS
®
ONCOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
NMSC:
Strategies for drug resistance, combination therapies, adjuvant radiation, post-op chemoradiation from page 64
evidence, there are no universally
adopted g u idel i nes on adjuva nt
radiotherapy in patients at high risk
for relapse after surgical management of NMSC. However, this issue is
addressed in the National Comprehensive Cancer Network (NCCN) guidelines based mainly on Level 2a evidence derived from findings of retrospective series,” he explains.
“There are four main groups of patients who warrant evaluation by a multidisciplinary tumor board and treatment with adjuvant radiotherapy based
on their risk for recurrence—patients
who are immunosuppressed and those
with locally advanced primary disease
(stage T3-T4), regional nodal metastasis,
or clinical perineural invasion.”
Focusing on patients with head and
neck NMSC, Dr. Porceddu adds that referral to a multidisciplinary tumor board
is also recommended in other situations
due to case complexity. They include patients whose tumor creates cosmetic or
functional concerns due to its location
(e.g., lips or eyes), those with multiple
primary lesions or distant metastases,
and if there is difficulty obtaining clear
margins without causing major morbidity such as orbital exentoration.
ADJUVANT RADIOTHERAPY
Dr. Porceddu notes that various retrospective series show adjuvant radiotherapy’s benefit for improving locoregional
control and disease-specific survival in
patients with locally advanced disease,
such that their outcomes are improved
by about 10% to 20% relative to patients
treated with surgery alone.
Regarding adjuvant radiation for
patients with perineural invasion, the
recommendation applies only to those
with clinical findings of large nerve involvement and does not include patients
in whom perineural invasion is found
incidentally at surgery. For patients with regional nodal metastasis, the most common sites of involvement are the intra-parotid nodes
followed by the cervical nodes. The re-
A role for adjuvant chemo-radiotherapy
TROG 05.01 (POST Study)
cSCC of the head & neck
Surgical removal of all macroscopic disease
High risk features
High risk nodal disease
Advanced primary disease
Randomisation
Radiotherapy alone
Radiotherapy & Chemotherapy
(Carboplatin)
There is a lack of Level 1 evidence to guide the use of adjuvant chemo-radiotherapy. National Comprehensive Cancer Network guidelines, which are based on extrapolation of data for mucosal head and neck SCC, recommend it
for patients who have lymph node metastasis or extracapsular extension. Outcomes data from the TROG 05.01;
NCT00193895 study, which compared postoperative radiotherapy and postoperative chemoradiotherapy in this
population will hopefully provide guidance. Source: Jean Y. Tang, M.D., Ph.D.
lapse rate for this population varies widely,
from 20% to 80%, and depends on the extent of nodal disease (involved node size
and number) as well as various pathological features. Findings predicting an increased risk for relapse include extracapsular extension, positive/close margins,
dermal or in-transit metastases, and invasion into surrounding structure, as well as
recurrence after primary surgery and immunosuppression.
“Addition of radiotherapy to surgery in
patients with regional nodal metastasis
was reported in one study to improve the
5-year disease free survival rate from 54%
to 73%,” Dr. Porceddu says.
Patients who are immunosuppressed,
either because of disease (eg. chronic lymphocytic leukemia) or medication use are
not only at increased risk for developing
NMSC compared to their immunocompetent counterparts, but they are also more
likely to have high risk features, such as
perineural invasion, as well as higher risks
of locoregional recurrence and mortality. “For these reasons, adjuvant radiotherapy should be considered for any immunosuppressed patient with a primary
NMSC larger than 2 cm,” Dr. Porceddu
says.
POST-OP CHEMORADIOTHERAPY
As for adjuvant chemotherapy for cutaneous NMSC of the head and neck, there is
also a lack of Level 1 evidence to guide its
use, Dr. Porceddu says. According to the
NCCN guidelines, it is recommended for
patients who have lymph node metastasis or extracapsular extension.
“The NCCN recommendation is based
on extrapolation of data for mucosal head
and neck SCC. However, we hope to have
an answer to whether chemoradiotherapy has a role in high risk cutaneous SCC
soon as the Trans Tasman Radiation Oncology Group has completed a randomized trial comparing postoperative radiotherapy and postoperative chemoradiotherapy in this population (TROG 05.01;
NCT00193895),” Dr. Porceddu says. (See
figure) “Accrual of the more than 320 patients targeted for enrollment is complete,
and follow-up is ongoing. Outcomes data
are expected to be released in the first
quarter of 2016.” DT
Dr. Tang and Dr. Porceddu have no relevant financial interests to disclose.
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®
OF DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
YOUR ASSETS EXPOSED?
76 ARE
Common myths and misconceptions about
asset protection — revealed and explained.
VERSUS LOYALTY
80 SATISFACTION
One gets you by...the other ensures you
thrive. Learn techniques for bridging the gap.
How to fire a problem patient
JOHN JESITUS | STAFF CORRESPONDENT
Dismissing a troublesome patient requires a firm stance and a soft touch,
says Jeanine Downie, M.D., a Montclair,
New Jersey-based dermatologist.
Because she appears regularly on
television, she says she
occasionally encounters patients who seem
to believe she is a magician. “And I’m not—
I’m simply a doctor
who is trying to work
on their image, their Dr. Downie
acne, or whatever their skin issues are.”
Sometimes, patients are problematic enough that they may need to be
dismissed from the practice — whether
because of inappropriate behavior in
the office, no-shows for appointments,
or other reasons.
Dr. Downie counsels, “be respectful and professional when firing a patient. Understand that feelings may be
hurt. ... Try to exude positivity. I always
tell them, ‘It’s not really you—it’s me.’”
SEND A LETTER
When dismissing a patient, “You must
QUICK READ
Problematic patients may
need to be dismissed from
your practice — whether
because of inappropriate
behavior in the office, noshows for appointments,
or other reasons. One
expert advises appropriate
and tactful ways to end a
physician-patient relationship.
send a certified letter, return receipt
requested, as well as a copy by U.S.
[Postal Service] mail. Photocopy both
items and put them in the patient’s
chart, after they’re stamped and before they’re sent.” Often, she says, patients will not sign the certified letter.
“So they still get a copy in the mail.”
The letter should detail the incident and date of inappropriate behavior by the patient, Dr. Downie
says. It also should advise the patient
that within 30 days of their receiving the letter, you will no longer be
providing their medical care. “That’s
critical—you cannot abandon them
right away” without facing possible
legal repercussions.
Quotable
THE MENTALLY UNSTABLE PATIENT
If she can detect that a prospective patient is not mentally stable, Dr. Downie
PROBLEM PATIENTS see page 75
DTExtra
Industry heads won’t snap in
the direction of flash-in-thepan, quick-fix leads. Hard
work, intellectual curiosity,
and dedication to science seem
to be the recipe for success in
clinical research.”
Melanie Palm, M.D.
A mobile strategy is your plan for
developing your presence and interactions
where your patients, increasingly, are looking for
you: on their mobile devices. If patients search for
your specialty from their mobile devices in your
region, do they find you? Are you doing anything
to reach them beyond an advertisement in the
local yellow pages? Medical Economics explores
ways that you can effectivly take advantage
of technology to generate new business and
keep your patients happy and connected.
Industry perspective on research
SEE STORY PAGE 78
Also in the letter, “Refer the patient
to his or her primary care physician,
insurance company, local hospital or
the county medical society to locate
another board-certified dermatologist. Keep it distant and cordial—inform the patient that there are many
other competent practitioners in the
area,” she advises.
Addit iona lly, t he let ter should
spell out the medical consequences
of failing to follow up with another
board-certified dermatologist.
“You don’t want to be in court later
with the patient saying you abandoned him or her, and there’s no paper work regarding what their sequelae would be” without further
treatment.
Although it’s not legally required,
she adds, “You can enclose a copy of
the medically relevant records to assist the patient in their exit from your
practice and facilitate their subsequent medical care.”
Medical Economics, bit.ly/telestrategy
TINEA
Due to Trichophyton rubrum and Epidermophyton floccosum in adults
STRIKE NOW. TREAT FAST.
2 weeks, 14 doses for tinea pedis; efficacy seen at 4 weeks post-treatment
1 week, 7 doses for tinea cruris and tinea corporis; efficacy seen at 3 weeks post-treatment
LUZU may help some patients with interdigital tinea pedis become fungus free. Individual results may vary.
Indications and Usage
LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis
caused by the organisms Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older.
Important Safety Information
LUZU is indicated for topical use only and is not indicated for ophthalmic, oral or intravaginal use.
LUZU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when LUZU is prescribed for nursing mothers.
The most common adverse reactions in clinical trials were application site reactions, which occurred in less than 1%
of subjects in both LUZU and vehicle arms. Most adverse reactions were mild in severity.
Please see Brief Summary of full Prescribing Information for LUZU on adjacent page.
®/TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product or brand names and logos are the property of their respective owners.
©2015 Valeant Pharmaceuticals North America LLC. DM/LUZ/15/0131b
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
FOR LUZU (luliconazole)
This Brief Summary does not include all the information needed to use
LUZU safely and effectively. See full Prescribing Information for LUZU.
noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).
Increased incidences of skeletal variation (14th rib) were noted at 25
mg/kg/day. No treatment related effects on skeletal variation were noted at 5
mg/kg/day (0.6 times the MRHD based on BSA comparisons).
LUZU (luliconazole) Cream, 1% for topical use
Initial U.S. Approval: 2013
Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were
administered during the period of organogenesis (gestational days 6-18) to
pregnant female rabbits. No treatment related effects on maternal toxicity,
embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times
the MRHD based on BSA comparisons).
Rx Only
INDICATIONS
LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the
topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis
caused by the organisms Trichophyton rubrum and Epidermophyton
floccosum, in patients 18 years of age and older.
DOSAGE AND ADMINISTRATION
For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or
intravaginal use.
When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1%
should be applied to the affected area and approximately 1 inch of the
immediate surrounding area(s) once daily for
two (2) weeks.
When treating tinea cruris or tinea corporis, LUZU Cream, 1% should be
applied to the affected area and approximately 1 inch of the immediate
surrounding area(s) once daily for one (1) week.
ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug, and may not reflect the
rates observed in practice.
In three Phase 3 clinical trials, 616 subjects were exposed to LUZU Cream,
1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris.
Subjects with interdigital tinea pedis or tinea cruris applied LUZU Cream, 1%
or vehicle cream once daily for 14 days or 7 days, respectively, to affected and
adjacent areas. During clinical trials with LUZU Cream, 1% the most
common adverse reactions were application site reactions which occurred in
less than 1% of subjects in both the LUZU and vehicle arms. Most adverse
reactions were mild in severity.
Post-Marketing Experience
The following adverse reactions have been identified during postmarketing
use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these
reactions are reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
DRUG INTERACTIONS
The potential of luliconazole to inhibit cytochrome P-450 (CYP) enzymes
1A2, 2C9, 2C19, 2D6, and 3A4 was evaluated in vitro. Based on in vitro
assessment, luliconazole at therapeutic doses, particularly when applied to
patients with moderate to severe tinea cruris, may inhibit the activity of
CYP2C19 and CYP3A4. However, no in vivo drug interaction trials have been
conducted to evaluate the effect of luliconazole on other drugs that are
substrates of CYP2C19 and CYP3A4.
Luliconazole is not expected to inhibit CYPs 1A2, 2C9 and 2D6 based on in
vitro assessment. The induction potential of luliconazole on CYP enzymes has
not been evaluated.
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies of LUZU Cream, 1% in
pregnant women. LUZU Cream, 1% should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
The animal multiples of human exposure calculations were based on daily
dose body surface area (BSA) comparisons (mg/m2) for the reproductive
toxicology studies described in this section and in Section 13.1 of the
prescribing information. The Maximum Recommended Human Dose
(MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg
individual which is equivalent to 49.2 mg/m2/day).
Systemic embryofetal development studies were conducted in rats and rabbits.
Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered
during the period of organogenesis (gestational days 7-17) to pregnant female
rats. No treatment related effects on maternal toxicity or malformations were
In a pre- and post-natal development study in rats, subcutaneous doses of 1, 5
and 25 mg/kg/day luliconazole were administered from the beginning of
organogenesis (gestation day 7) through the end of lactation (lactation day
20). In the presence of maternal toxicity, embryofetal toxicity (increased
prenatal pup mortality, reduced live litter sizes and increased postnatal pup
mortality) was noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5
mg/kg/day (0.6 times the MRHD based on BSA comparisons). No treatment
effects on postnatal development were noted at 25 mg/kg/day (3 times the
MRHD based on BSA comparisons).
Nursing Mothers
It is not known whether luliconazole is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when
LUZU Cream, 1% is administered to women who are breastfeeding.
Pediatric Use
The safety and effectiveness of LUZU Cream, 1% in pediatric patients have
not been established. The number of pediatric patients 12 years of age were
too small to adequately assess safety and efficacy.
Geriatric Use
Of the total number of subjects in clinical studies of LUZU Cream, 1%, 8
percent were 65 and over, while 1.4 percent were 75 and over. No overall
differences in safety or effectiveness were observed between these subjects
and younger subjects, and other reported clinical experience has not identified
differences in responses between the elderly and younger patients, but greater
sensitivity of some older individuals cannot be ruled out.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the carcinogenic potential of LUZU Cream, 1%
have not been conducted.
Luliconazole revealed no evidence of mutagenic or clastogenic potential
based on the results of two in vitro genotoxicity tests (Ames assay and
Chinese hamster lung cell chromosomal aberration assay) and one in vivo
genotoxicity test (mouse bone marrow micronucleus test).
In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day
luliconazole were administered prior to and during mating and through early
pregnancy. Treatment related effects on reproductive function were noted in
females (decreased live embryos and decreased corpus luteum) at 5 and 25
mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment
related effects on fertility or reproductive function were noted at 1 mg/kg/day
(0.1X MRHD based on BSA comparisons).
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
Inform patients that LUZU Cream, 1% is for topical use only. LUZU Cream,
1% is not intended for intravaginal or ophthalmic use.
Manufactured for:
Medicis, a division of Valeant Pharmaceuticals North America LLC,
Bridgewater, NJ 08807
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Product of Japan
Issued: 8/2014
9386401
DM/LUZ/15/0007
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
BUSINESS OF DERMATOLOGY
PROBLEM PATIENTS:
Know when enough is enough from page 72
says, she politely refuses to treat the
person in the first place.
C onv er s el y, D r. D o w n ie s a y s
she’ll gladly treat a patient who has
psychiatric issues if the patient is
receiving proper mental health care,
is participating in a dialogue with
her and is following treatment recommendations.
THE NO-SHOW PATIENT
Less urgent, but still problematic, said
Dr. Downie, is the no-show patient,
who wreaks havoc with a practice’s
schedule and patient flow. Before taking action, “Always listen to what their
circumstances happen to be.” For example, she says, having chemotherapy trumps “The dog ate my appointment card.”
Ultimately, “If it’s more than three
no-shows, and you feel you’re not
connecting with the patient, abso-
lutely fire them,” she says. “Explain
in your letter to them that it’s due to
their failure to present or cancel in
an appropriate amount of time before
their scheduled appointments. Tell
the patient that you will make their
medical records available to them
when they pick another dermatologist.” With your letter, “Enclose an authorization form saying that you need
a signed medical release to ship the
records out. And always extend your
best wishes to the patient.”
IF PROBLEM PATIENTS COME TO CALL
Because many problem patients are
quite confrontational, Dr. Downie
says, they may show up at the practice within the 30-day window, demanding to see the dermatologist. If
this happens she says, “Do not see the
patient alone in a room. Have your
nurse, assistant or other staff mem-
ber present in the room to lessen the
likelihood that the patient can claim
you did something inappropriate.”
Even if the patient says he or she
does not want another person in the
room, Dr. Downie emphasizes, “You
can still talk to them in a semi-private
area and have somebody standing by.”
She relates that a colleague who failed
to take such precautions had to settle with a patient who had completely
fabricated a claim of impropriety.
Somewhat similarly, “If a patient
comes in and debates you, tell them
that your decision is final, and it’s in
both of your best interests. You might
have to repeat yourself three or four
times,” she says.
“The bottom line is, if you feel
threatened in any way, don’t hesitate to call the police.” DT
Dr. Downie reports no relevant financial interests.
75
76
BUSINESS
®
OF DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
David B. Mandell, J.D., M.B.A.
is an attorney and author, as well as a
principal of the financial consulting firm
OJM Group.
Carole C. Foos, C.P.A.
works as a tax consultant at OJM Group.
Are your assets exposed?
A
sset protection is a crucial but
often overlooked part of financial planning. Misperceptions and
myths abound in conventional wisdom
when it comes to asset protection, ranging from “you don’t need to worry about
asset protection, you have insurance” to
“just put the assets in your spouse’s name
– it’ll protect you.” Here, we examine several of these common misperceptions.
➊ “Your Insurance Protects You”
Property and casualty (P&C) insurance is an important part of any asset
protection plan, but an insurance policy
that is 50 pages long rarely gets read
by the buyer, let alone analyzed or understood. Insurance policies all have
a variety of exclusions that can create
unexpected gaps in coverage. This is
true for personal policies, like homeowner’s, car and even umbrella insurance; as well as business policies, the
most important of which for physicians
is medical malpractice.
Even if your policy does cover the
risk in question, there are still risks of
the claim going beyond coverage limits
(malpractice judgments do periodically
exceed traditional $1/3 million coverage), strict liability, and bankruptcy of
the insurance company. In any of these
cases, you could be left with the sole
responsibility for the loss. In addition,
even if all of your losses are covered
within coverage limits, a claim could
cause future premiums to skyrocket.
For these reasons, it is unwise to rely
solely on insurance for your protection,
especially when many asset protection
techniques will generally save taxes
and help you build retirement wealth.
Don’t Need a
➋ “You
Professional Corporation (PC)”
The main justification for this point of
view seems to be the expense ($1,000
or so to create, and a few hundred
dollars per year) and the additional
paperwork (tax return, minutes, etc.).
However, when you fail to use a PC or
other similar entity (PA, PLLC) to run
your practice, you expose all of your
personal wealth to any claim originating
in the operation of the practice. While the PC will not protect your
assets from malpractice, it does take
into account other liability risks created
by employees. For example, consider
car accidents employees might get in
when driving for the business (receptionist going to pick up lunch for the office) or a slip and fall in the office, or car
accident in the parking lot, among many
others. Implemented correctly, a PC
protects your personal wealth against all
of these potential liabilities and more—
without one, all of your personal wealth
could be vulnerable.
a ‘Disregarded Entity’
➌ “Use
for Tax Purposes”
Related to the mistaken notion that a
physician should avoid using a PC is
this more-common misguidance for
solo physicians; to have a professional
entity, but to choose to have the entity taxed as a “disregarded entity” by
the IRS. Essentially, a sole-owned LLC
can elect not to be treated as a separate entity but, instead, to be treated
as a “disregarded entity” where the
profits or losses simply flow to Schedule C of the tax return of the sole
owner (physician). Unfortunately, with
this strategy, the physician assumes
the same risk as having no entity at
all, and a lawsuit against the practice
could potentially attack all of the doctor’s personal assets, even if he was
totally uninvolved in the activity that
created liability.
Put Your Assets in Your
➍“Just
Spouse’s Name”
Many people believe erroneously that
assets in a spouse’s name cannot be
touched. To see how this legal interpretation is wrong, ask yourself:
Whose income was used to purchase the asset?
Has the doctor used the asset at
any time?
Does the doctor have any control
over the asset?
Has the doctor benefited from “the
spouse’s assets” in any way?
If the answer is “yes” to any of
these questions, most courts find that
at least half of the value will be exposed to the claims against the doctor. In community property states, it
may be 100% of the value, as a community asset.
Another good litmus test is to ask
your financial advisor what she thinks
will happen in a divorce if you put all
the assets in the spouse’s name. It’s
a safe bet that your advisor will say
that the court will treat these assets
as joint because you are still treating them as joint (living in the house,
spending the accounts, paying the
taxes). Therefore, the court knows that
you haven’t really given the assets
away to the spouse. Most likely, this is
exactly the way the court will treat the
assets for creditor purposes as well.
HOW TO PROTECT YOURSELF
Each physician has a differing set of
circumstances and needs. Consulting
with tax and legal professionals before
implementing any financial strategy
can provide you with the background
knowledge you need to create an approach that will protect your assets.
Tax laws change frequently, so regular
consultation with your professional tax
advisor is key.
The general information presented
here may not be suitable for everyone
and should not be construed as personalized legal or tax advice. DT
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78
BUSINESS
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OF DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Melanie D. Palm, M.D.,
is director of Art of Skin in
Solana Beach, California
Industry perspective on research
n last month’s column we explored the
physician perspective for entrée into
the sphere of clinical research. This
month’s column reveals the industry perspective on what is valuable in a
physician regarding clinical studies, with
three industry insiders providing a fair
appraisal of the qualities and qualifications they seek in physicians partnering
with industry in research.
I
or a review of the literature, according to
Nogueira. Gallagher advises that “the best
way to get involved in clinical research
is [by] acting as a sub-investigator for an
experienced investigator on a company
sponsored clinical trial.” He asserts this is
an excellent opportunity to build a skill set
required for a successful physician clinician. Besse suggests that being a part of a
multi-site study is another excellent oppor-
“The best way to get involved in clinical
research is [by] acting as a sub-investigator
for an experienced investigator on a
company sponsored clinical trial.”
is really a labor of love,” adds Gallagher.
HOW TO BE SUCCESSFUL
OVER THE LONG HAUL
Integrity, work ethic, and attention to detail are
common themes among feedback from industry experts. Research is a laborious endeavor—
proper staffing, facilities, and ethical behavior
are required to be successful over a significant
period of time. Another quality is worth noting: humility. “Receptiveness to feedback from
company staff inspecting the site is important,”
stresses Gallagher. Consider how you lead your
staff as well, as others are observing. According to Besse, “Physicians who command respect within their practices (which never comes
without showing mutual respect to their staff)
have clinical teams that are dedicated to their
patients and their outcomes.”
Conor Gallagher, Ph.D.
Director of Medical Affairs, Allergan
These experts’ experience encompass a broad landscape of dermatology,
from medical to aesthetic dermatology,
medications to devices, and personal
education from M.D. to Ph.D. and businessperson. Special thanks to Conor
Gallagher, Ph.D. (Director of Medical Affairs, Allergan), Alessandra Nogueira, M.D.
(Aesthetics & Corrective Medical Director,
Galderma), and Marcel Besse (Executive Director, Lutronic & former President
North America, BTL Industries) for their
participation.
HOW AND WHERE TO START
If you have a research concept, these experts agree that discussing it with an appropriate company medical science liaison
(MSL) is the first appropriate step. According to Gallagher, “MSLs will be able to discuss research capabilities and experience
and pass on the information to the appropriate group in the company Clinical Development or Medical Affairs departments.”
What type of study to start varies and
there are multiple avenues to success.
Novices in the field might benefit from conducting a small study that is observational
INDUSTRY CHANGES AHEAD
tunity, especially if a trial is straightforward
and without requirements for pain management, histology or invasive procedures.
HOW TO GET NOTICED
Industry heads won’t snap in the direction
of flash-in-the-pan, quick-fix leads. Hard
work, intellectual curiosity and dedication
to science seem to be the recipe for success in clinical research.
“Most companies like to work with
well-established and well-respected luminaries as well as experienced young
leaders,” states Besse. Past publications, a well-organized and trained research team, and proper educational
training are key qualifications for selection as an investigator. Attending and
presenting at scientific meetings such
as the AAD and the SID impart credibility to your name, according to Nogueira. Gallagher highlights the importance
of proper motivations for participating in
research. It requires significant energy,
passion, curiosity, and time. “Investigators should not expect to get involved in
research for the money. While investigators are compensated for their efforts, it
“Formal research and regulatory compliance training today [are] essential,” stresses
Nogueira, noting that, if pursuing a formal degree in the area of research is not feasible for
a busy clinician, it is important for physicians
to attend compliance and research courses
at national meetings such as the AAD or
through the FDA.
It is important to remain realistic and not
be discouraged by setbacks. Gallagher notes
that the environment of industry consolidation
has led to a contraction in research opportunities. Even well-seasoned clinicians are not
always selected for some studies for which
they would be an ideal fit. Perseverance is
definitely required, but within reason. Within
the aesthetic sphere, Besse comments that
financial rewards for the company and physician should not affect research outcomes.
“Physicians should avoid pressures with conducting clinical studies with any bias toward
the outcomes that all desire. We all must work
together to insure that clinical studies best
translate into quality outcomes and ultimately
the true goal—happy patients.” DT
Questions? Comments?
Give Dermatology Times your feedback by
contacting us at [email protected].
80
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SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
Cheryl Bisera is a marketing consultant, author and
speaker with extensive experience in marketing and
business promotion. She is founder of Cheryl Bisera
Consulting, a California-based image development and
marketing company that focuses on the healthcare industry.
Ms. Bisera is also the co-author of The Patient-Centered
Payoff, published by Greenbranch Publishing.
Satisfaction gets you by;
Loyalty ensures you thrive
H
ave you ever considered the difference between patient satisfaction and patient loyalty? One gets you by, the other ensures you
thrive. In reality, a ‘satisfied’ patient might simply not be bothered enough to change practices. In other words, they may not be
wowed but they stay because it’s inconvenient to switch and their basic
needs are being met. Once this type of patient has an alluring alternative—an enthusiastic referral from a friend, an uber-convenient pharmacy
clinic close to home or an enticing special—they’ll change practices without batting an eye. The worst part is that you might not even know that
they left at all…or why. Even high patient-satisfaction rates cannot be
interpreted as patient loyalty; loyalty is on a whole other level.
Loyal patients will weather changes
in your practice because there is
something so good at your practice
that they can’t conceive of finding it
better anywhere else. They also enthusiastically evangelize for your practice, sending friends and family your
way. Patient referrals are your most
powerful marketing tool, no small gift!
And…it’s personal. After all, prices,
insurance, and décor change, but they
won’t get you and your staff at another
practice. For this reason, relationship
is at the core of what makes a patient
loyal to a practice. But, if service
stinks, access is poor and the décor is
outdated, the message that “we don’t
care” comes through and dampens
the relationship. It’s more than looking
into the eyes of patients and listening,
though that is so powerful; it’s about
dialing in the patient experience and
building the relationship!
can look deceivingly healthy but this is
an expensive, unsustainable and far less
satisfying model.
It’s likely you fall somewhere in the
middle: you have a few loyal patients who
refer to you, but you suspect that your
‘satisfied’ patients are there because
you are contracted with their insurance
and because you’re the most convenient
choice. If you want to take control and
strengthen your practice through patient
loyalty, I have good news. All the things
that garner patient loyalty are simply great
business principals anyhow; you have
nothing to lose and everything to gain!
THE HOLY GRAIL OF CUSTOMER SERVICE
Patient loyalty is like the holy grail of customer service in the medical practice.
If you can find that sweet spot, it won’t
matter what shiny new thing rolls into
town – your practice will be rock solid and
thriving. I’ve seen the practices that have
it and I’ve seen those that don’t. On one
hand is a practice that seems to endure
the test of time; long-time patients are
the norm and they usually don’t need to
advertise. In fact, these practices often
can’t accommodate all their new patient
requests. On the other hand is the practice that must constantly strive to attract
new patients to replenish those who are
lost through attrition. This is sometimes
done by accepting less-than-attractive
insurance contracts, which can force a
practice to have to see more patients in
less time, driving service lower and contributing to a vicious cycle of downward
spiraling quality. The influx of new patients
MAKE IT HAPPEN
Here are some ways your practice can
nurture patient loyalty through stronger
patient-clinic and patient-physician
relationships:
every new patient like you
➊ Treat
would an important guest.
They should be introduced to staff,
shown around and welcomed to the
practice — celebrate their first visit and
leave an incredible first impression!
➋ Express appreciation.
Find ways to thank patients for
continuing to choose you. Never miss an
opportunity to say ‘thanks,’ especially if
a patient has referred someone to you.
Mind wait times, access to
➌
appointments and perceived
time with the physician.
What’s your most effective patient satisfaction technique? Tell us at [email protected]
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
These time issues are extremely important to patients, enough to drive
an otherwise happy patient away.
The first two can be resolved with
a scheduling template that allows
adequate time for each patient, starting on time and eliminating the lunch
time shut-down—improving access
by keeping phone lines open. The
later means making the patient feel
like they had the full attention of their
physician. Some ways to do this include using body language, eye contact and asking if they have any questions or concerns.
as much
➍Communicate
as possible.
You really can’t over communicate.
Let patients know what you expect
and what they should expect as often
as possible. This could include early
communication about payment and
payment options, appointment reminders, opportunity to ask questions,
using their name and communicat-
ing rescheduling options when
the practice is running behind.
This kind of communication
expresses respect and makes
patients feel comfortable and in
control.
out what they want and
➎ Find
give it to them.
BUSINESS OF DERMATOLOGY
NEXT MONTH
will focus on
how to effectively
use patient surveys
to give your practice
a competitive
advantage.
Through patient surveys you can find
out what they are pining for before
someone else offers it. For example,
you might find out that your patients
would take advantage of Saturday
hours and decide to have a provider
available for a monthly Saturday clinic.
BRIDGING THE LOYALTY GAP
To really find out where you stand in the
loyalty gap—the process of turning satisfied patients into loyal patients—it’s crucial to survey patients and give them
alternative avenues of giving honest feedback. Remember to ask them how willing they are to refer a family member or
friend, and track where new patients are
coming from to find
out if that is in fact
happening. Patient
feedback will help
you know what kinds
of service changes
can bridge that gap
and convert them into
loyal, referring patients.
It’s equally important to have a staff that
embraces feedback and the challenge of
using every opportunity to strengthen the
patient-clinic relationship.
It’s worth mentioning that even if you
have attained the holy grail of patient
loyalty; you always have to be ready for
a curve ball. Tomorrow a shiny new thing
might roll into your town, so keep minding the gap between patient satisfaction and patient loyalty by nurturing patient loyalty all the time, regardless of
your current success. Then you can reap
the benefits of a thriving practice full of
patients that refer and a practice culture
that’s satisfying for both patients and
practice members! DT
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81
82
BUSINESS
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SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
From the pages of
The battle over EHR patient data
How to secure your access to patient data when switching electronic health record vendors
JOHN MORRISSEY | STAFF CORRESPONDENT
Who owns patient data in an electronic
health record (EHR)? It’s a simple question
with a complex answer. No longer confined to the shelves of a physician’s office,
patient data is now shared and used by a
myriad of organizations across healthcare:
Other physicians and health systems, the
EHR vendor, payers, and researchers, not
to mention patients themselves. While
primary care physicians often originate
the medical record, the resulting data are
not theirs alone.
The implication? The traditional concept of ownership is unraveling as patient data migrates away from paper
charts and takes up residence in the
cloud. Experts now counsel physicians
against the concept of data ownership
entirely. Instead, they encourage physicians to consider themselves “stewards”
of the data within their possession and
administrative control.
This grey area has serious consequences for physicians, particularly concerning their relationship with their EHR
vendors, the third party who has most
access—and control—over patient data.
Too often, physicians give vendors the
upper hand on data rights by not addressing them when drawing up the contract, says Adam Greene, J.D., a partner
with the law firm Davis Wright Tremaine
and an expert on healthcare technology
and privacy.
“To be perfectly blunt, more often than
not, these details are not addressed up
front,” Dr. Greene says. “You have pretty
generic language, and oftentimes that
can come back to haunt the physician.
Questions of data rights should be
“top of mind when they’re contracting,”
he adds. “And if they feel like the contract with the EHR vendor does not provide enough details on this front, they
should ask the questions, and if they feel
like they need to get the answers in writing, they should push for that.”
It can prevent trouble down the road.
Full Circle Health Care, a physician’s
practice in Presque Isle, Maine, had its
access to data for 4,000 patients blocked
by its EHR vendor after a dispute over
billing practices, according to a report
in the Boston Globe.
“I’m incredulous they think it is OK
to hold us hostage like that,” E. Victoria
Grover, a physician assistant and the
practice owner, told the newspaper.
T he key: protect your pract ice
with a contract that clearly spells
outs how and when an EHR vendor
can use patient data.
LEVERAGING YOUR POSITION
One point is clear: EHR vendors do not
have outright ownership of patient data,
even if it lives within their system.
Under the Health Insurance Portability and Accountability Act (HIPAA), business associates, including EHR vendors,
must return or destroy patient health
information upon termination of the
agreement, Dr. Greene says.
“That really kind of undercuts any
claim that they have ownership,” Dr.
Greene says. “While HIPAA doesn’t use
the word ownership in any place, it undermines any argument that the vendor
owns the data.”
The agreement with the vendor, then,
must be about more than wrangling an
affordable price, says Deven McGraw,
J.D., a healthcare attorney with the firm
Manatt, Phelps & Phillips.
In practice, the EHR vendor may be
the more powerful party, particularly in
negotiations with small practices, McGraw says. Not reading or understanding contract terms can lead physicians
to sign away “pretty significant rights to
that data” to the vendor. During negotiations, physicians should clearly spell
out EHR data rights in the business associates agreement and contract with the
vendor. But many don’t take advantage
of this opportunity for leverage.
The consequences of overlooking
data rights can be severe for physicians,
McGraw says. The EHR vendor gains
the upper hand and increases the likelihood that physicians won’t have the
contract language needed to control the
relationship as a customer. Furthermore, it can limit their ability to migrate the data easily and inexpensively
to a new EHR vendor in the event of a
future decision to part ways.
It’s never too late to revisit the contract in an attempt to address these issues, even if the contract has already
been signed, and a practice realizes
it didn’t pay enough attention to data
rights, Dr. Greene says. But success “frequently comes down to a matter of leverage.” Unfortunately, the only option a physician would have is to say
they don’t like the terms and to go elsewhere. Physicians have limited leverage to negotiate these contracts with
big EHR vendors, even at the beginning,
but “there’s nothing barring a physician
from trying to do so.”
Every physician negotiating a contract with a vendor should have the right
to unfettered data access for patient
care and follow-up, quality improvement, patient management, reporting and overall population health, says
Mary Griskewicz, M.S., F.H.I.M.S.S., senior director of healthcare information
systems for the Healthcare Information
and Management Systems Society.
That’s not to say EHR vendors have
no claim to the use of data residing in
their products. The terms of the associate agreement and the purchase contract can grant vendors an array of permitted uses that are within HIPAA parameters, Dr. McGraw says.
To sweeten the deal, a vendor may
reduce the price of services such as record management “in exchange for the
ability to mine data out of the record,”
Dr. McGraw adds. HIPAA limits don’t
apply to data that are de-identified, e.g.
stripped of elements that could trace the
identity of patients.
The business associates agreement,
Dr. Greene says, should bind the vendor
to use or disclose data only in the same
manner as the healthcare provider can
under HIPAA, in addition to these two
provisions:
EHR DATA see page 84
EFFACLAR DUO
DUAL ACTION ACNE TREATMENT
1
An antibiotic-free benzoyl peroxide acne treatment
Clinically tested to be as effective as a leading benzoyl
2
peroxide/antibiotic prescription
Baseline
Week 2
Week 12
· 5.5% Micronized Benzoyl Peroxide acne medication
· Micro-exfoliating LHA (derivative of Salicylic Acid) for precise exfoliation
High tolerance
Oil-free/Non-comedogenic
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Tested on sensitive skin
Significant reduction of acne lesions
INFLAMMATORY LESION COUNTS2
NON-INFLAMMATORY LESION COUNTS2
0%
-25%
-31.9%
-50%
-46.9%
-55.2%
-59.7%
-75%
-65.7%
-65.8%
-63.3%
-68.4%
-100%
% CHANGE FROM THE BASELINE
% CHANGE FROM THE BASELINE
0%
-25%
-50%
-31.1%
-44.7%
-37.4%
-57.5%
-63.1%
-57.9%
-63.8%
-75%
-65.2%
-100%
Baseline
*Week 2
*Week 4
*Week 8
■ Leading acne Rx + topical retinoid [0.025%]
■ EFFACLAR DUO + topical retinoid [0.025%]
*Week 12
Baseline
*Week 2
*Week 4
*Week 8
*Week 12
*P ≤ 0.001
(1) Dual action acne treatment stems from Benzoyl peroxide.
(2) Protocol: A 12 week dermatologist controlled, multi-center study: double blind clinical trial to evaluate safety and efficacy of two acne creams in subjects with mild to moderate acne vulgaris. 61 patients, ages 18–50, multiethnic skin, all skin types. 2 cell study: Cell 1, 27 patients, [EFFACLAR DUO]+ 0.025% Topical Retinoid vs. Cell 2, 34 patients, [a leading topical Benzoyl peroxide prescription] + 0.025% Topical Retinoid. Results measured at
mean % change from baseline at 12 weeks of use. Application of topical retinoid applied once a day in PM and application of Effaclar DUO or a leading topical prescription Benzoyl peroxide twice a day. Inclusion criteria: ≥ 15
inflammatory lesions and ≥ 20 non-inflammatory lesions.
84
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®
OF DERMATOLOGY
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
EHR DATA:
How to bind the vendor to your advantage from page 82
➧ Permitting the vendor to perform data
aggregation to look at data across different covered entities and combine it
for analysis for the benefit of healthcare
providers;
➧ Allowing the vendor to use or disclose
information for the vendor’s own proper
management and administration and
to perform its legal responsibilities. For
example, a vendor might have to report
to the Food and Drug Administration,
or have an auditor review live data to determine security practices.
MAKING THE SWITCH
While haggling over the initial contract,
make sure terms are in place to protect
your practice if you decide to terminate
the relationship and switch to a different EHR vendor.
Physician dissatisfaction with EHRs
is at an all-time high, and many physicians are looking to change systems.
Yet questions about migrating data hang
over these transactions, often making
physicians leery about jumping ship
even when it’s the best decision for their
practice.
“A pretty significant number of practices either had to dump their own EHR
or are planning on doing it,” says Robert Tennant, senior policy adviser at the
Medical Group Management Association (MGMA). “So the question becomes:
what do you do then? Yes, they own the
record, but it’s not in a format that easily
translates over to the new one.”
Making matters worse, the situation
calls for the loser of a customer to cooperate with the winner. “There’s not much
incentive for EHR vendors to make it easy
for their customers to take their business
elsewhere,” Dr. Greene says.
That possible scenario heightens the
need to review the contract at the signing. One part of thinking through the
agreement is to identify issues about
what happens if you want to leave a specific vendor; and add that to the contract.
If that day arrives, the responsibilities are
already spelled out.
Consider, though, that a vendor may
reserve continuous rights to a departing
provider’s data, Dr. McGraw says. The
return-or-destroy requirement applies
only to patient health information, and
“it doesn’t necessarily cut off the business associate from being able to con-
tinue to use the de-identified data that
they may have created from the identifiable data when they had it,” she explains.
Beyond data ownership questions,
switching vendors requires a challenging feat: migrating data that’s formatted
and optimized for one proprietary system into a new system.
“A particular vendor has designed
software, and the data are created in that
software, for that software, not created in
a manner that can be used by other vendors’ software,” Dr. Greene says.
Beyond data
ownership
questions,
switching vendors
requires a
challenging feat:
migrating data
that’s formatted and
optimized for one
proprietary system
into a new system.
SURVIVING THE SWITCH
If your practice is contemplating an EHR
switch, remember that it will be expensive, disruptive and riddled with technical issues related to data conversion.
Yet it could still be the best decision your
practice ever makes.
Five years ago, a 10-provider practice based in Independence, Missouri
became an early case of converting its
data to another EHR, at a cost of $65,000
above the purchase price of software
and implementation, says Bryan Wood,
practice administrator of Cockerell
& McIntosh Pediatrics. Starting over
without the data from the old system
was never considered.
“So we just did it and we just planned
on that extra cost,” Mr. Wood says.
The practice received its raw data,
written on “one compact disc, it didn’t
include much technical detail, or clues
as to what the elements represent.” With
a background in IT, Mr. Wood had to use
a computer tool to extract the data into
a more beneficial form. Then he worked
closely with database experts from the
new vendor to convert, test and refine
the data, a process that took four months.
Mr. Wood says his experience with the
new vendor’s database technicians was
positive, but not without hitches. For example, errors sprouted up because the
new system was looking for data elements that the old EHR did not collect,
such as additional immunization details.
There is no recourse for the manner in which data transfer takes place
if the original contract did not cover it,
Ms. Griskewicz says. “Vendors actually make money off providing that as
a service of the exit strategy,” she says.
“They can say that if it’s not in the contract, ‘Well, we can do this for X amount
of dollars.’” The price “depends on the
vendor, there’s no standard fee. It depends on the volume of the data that
you’re trying to migrate.”
It may also depend on the new vendor,
she adds. “You bring them in, have them
look at the file formats, the data — how
it was stored. Can they take that information and help you with the migration?
Because they’re going to be much more
motivated to help you down that road.”
Jernigan Surgery Clinic, a small practice in Union City, Tennessee, went live
with a new EHR in April. “They do everything they say; it pulls everything exactly
how you have it,” says Samantha Jernigan, practice administrator.
A vendor database specialist went
through the previous EHR’s data step by
step with her, asking whether a certain
data set should be pulled in or not. That
allowed the practice to cull some information fields with little use.
Practice and technical progress are
lowering the conversion bar even for
small practices, says Justin Barnes, formerly a healthcare IT executive and now
a consultant. “Due to unified standards,
innovative tools and the need for consolidated data and quality reporting, these
migrations have become much less cumbersome than in the past.” DT
Read the full article
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86 THE
TAKEAWAY
®
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
PART 3
Screening labs, complacency, and
the ABCDEs of pediatric melanoma
ELAINE SIEGFRIED, M.D.
In the final part of our discussion about pediatric dermatology, Kelly
Cordoro, M.D., associate professor of dermatology and pediatrics
at the University of California in San Francisco, discusses screening
labs, avoiding complacency, and the ABCDEs of melanoma with
Dermatology Times editorial advisor, Elaine Siegfried, M.D.
DR. SIEGFRIED: You wrote a great paper about
screening labs and the relative value of
screening labs when using systemic agents
for kids with psoriasis. Given whatever your
favorite drug is, which labs do you routinely
check and how often?
A Dr. Cordoro: Thank you. I really wanted to research more
about these drugs and what are the
differences. We get most of our information on screening from other
subspecialties: We borrow from the
rheumatology literature; we borrow
from the hematology-oncology literature; we borrow from the gastrointestinal literature. We don’t have our
own data-driven evidence for kids
with psoriasis specifically, or for kids
with atopic dermatitis specifically to
really answer these questions. So my
approach is very clinically driven.
I start out very conservatively. I
will check labs at baseline and fairly
frequently early in the course of
therapy. And the specific labs and
frequency differ depending upon the
specific agent used.
We know for cyclosporine, we have
to be more aware of checking blood
pressures, electrolyte levels and kidney function. With methotrexate, we
have to be more aware about testing
liver function and so forth.
Over the course of therapy and depending on the patient’s individual
situation, their response to disease
and lab results, I’ll check more or less
frequently. Even though we have published recommendations, your clinical
experience and the individual patient
will prompt a variable approach. I will
liberalize or tighten the lab monitoring
as the clinical course evolves.
In developing the AAD’s clinical guidelines for management and
treatment of atopic dermatitis with
phototherapy and systemic agents,
Listen to the discussion.
bit.ly/ABCDEsofpediatricmelanoma
we agreed on recommendations for
monitoring. Those were derived based
on available evidence and expert consensus.1
There are charts in the manuscript
detailing the dosing and recommendations, and I follow those pretty closely.
For psoriasis, my approach is similar. It’s really a more aggressive approach upfront and then adjustments
over time based on individual factors.
My recommendations around that
can be found in an article that Anne
Marqueling, M.D., our former pediatric
dermatology fellow who is now faculty
at Stanford, and I wrote called “Systemic Treatments for Severe Pediatric
Psoriasis: A Practical Approach.” This
contains straightforward and clinically
driven suggestions for baseline and
then ongoing monitoring.2
DR. SIEGFRIED: It is an advantage and a disadvantage that we don’t have a lot of high-tier,
evidence-based medicine, and so we have the
privilege of customizing treatment for our patients. Patients aren’t templates; they all have
unique issues that impact the best treatment
choice. What advice would you give to
new clinicians about this?
A Dr. Cordoro: Well said. I
think my advice to very
junior clinicians is to start
by the textbooks, go by
what’s been written by those
with more knowledge and experience. In general we tend to
be more cautious with monitoring
at first and then over time, the approach may evolve.
However, I will say this: I am
constantly humbled by these medications—both conventional sys-
temic therapies and biologics. We
have to be careful as we are modifying and customizing that we don’t
become complacent and say, ‘I’ve
been doing this for so many years,
we don’t have to check that anymore.’ Because as soon as we let our
guard down, we can get burned. So
the right answer is somewhere between being cost-effective and not
over-monitoring, but not getting too
comfortable either.
DR. SIEGFRIED: Do you check all kids that you
are going to put on any kind of immunomodulating therapy for TB risk?
A Dr. Cordoro: I do because I live
in a high-prevalence area in
the San Francisco Bay area. When
I practiced in Virginia, I did not. I
would routinely do it for TNF inhibitors, I routinely did it for methotrexate; and, right or wrong, I did not
do it for some of the other systemic
agents. Now of course I am doing it
for everybody and maybe everybody
should be doing it for every patient
with all of these medications.
TAKEAWAY see page 88
“We don’t
have our own
data-driven
evidence
for kids with
psoriasis...so
my approach is very
clinically driven.”
Kelly Cordoro, M.D.
San Francisco, Calif.
2015
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88 THE
TAKEAWAY
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SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
TAKEAWAY:
Biologics, screening, and pediatric melanoma from page 86
DR. SIEGFRIED: Are you doing purified protein
derivative (PPD) or QuantiFERON (Cellestis)?
A Dr. Cordoro: I am doing PPD (purified protein derivative) for the
most part. I think it’s the most costeffective screen. If we are not guaranteed that they will follow up on their
PPD and we can’t reach their pediatrician, then we will do a QuantiFERON.
However, data on performance are
scant in the pediatric age group. The
Centers for Disease Control and Prevention cautions use in patients less
than 17, and in particular in kids less
than 5 years old.
DR. SIEGFRIED: What biologics have you used?
A Dr. Cordoro: Well, as you well
know, all biologic treatments for
dermatologic use in kids are off-label,
as are all systemic medications for
psoriasis and atopic dermatitis. So
yes, I’m always prescribing off-label
and I use the TNF inhibitors the most.
I use this for recalcitrant plaque and
pustular psoriasis. I tend to prescribe
etanercept initially, because it has the
most data for kids. There has been
a randomized, controlled trial, as
you know, spearheaded by [Dr.] Amy
Paller.3 However, its efficacy often
wanes over time and may require a
transition to other TNF agents or a
class change.
I would say that I have the most experience with TNF inhibitors. I don’t
use them as much as I do systemic
therapies. I am still in the “drugs I
know and can monitor” phase of my
career. I have some concerns about
the lack of knowledge about long-term
risks of some of these agents. For example, I do not have a vast experience
with ustekinumab yet. I have prescribed it only one time to a teenager
with severe psoriasis who failed antiTNF.
For generalized pustular psoriasis,
my drug of choice is infliximab if I
need to achieve really rapid control. I
often accompany that by small doses
of methotrexate to block human antichimeric antibodies, which overtime
can lead to loss of efficacy and increased infusion reactions. I have not
used a biologic agent for the treatment
of atopic dermatitis.
DR. SIEGFRIED: Your publications have been
very diverse including a couple of really great
articles. Can you talk about what inspired the
ABCDEs for pediatric melanoma and the seminal
article on eczema coxsackium?
A Dr. Cordoro: Thank you for the
compliment. My articles have been
driven by my passion for dermatology
and the confusion that arises when
caring for complex patients. My patient care practice really dominates
the questions that I have asked.
The ABCDE story for pediatric
melanoma really began in my pediatric dermatology fellowship. As
I mentioned earlier, I transitioned
from being an adult dermatologist
to pediatric dermatology, and it was
profound for me when I realized how
differently melanoma can present in
children and that it could be missed
a large part of the time because of the
different clinical presentation.
I remember saying to my fellowship director and mentor, [Dr.] Ilona
Frieden, while caring for a young girl
with amelanotic melanoma, ‘The
ABCDEs do not always apply to pediatric melanoma. These kids are at
risk for very late detection. I want to
write this up.” This was in 2007. She
said, “Why don’t you collect data and
see if it supports your notion?” So, the
idea was born in 2007 and resulted in
a paper that was published in 2013.4 In
reviewing the literature on childhood
melanoma, I realized the paucity of
clinical information—in particular,
the original appearance of the melanoma—provided in published series. We reviewed the details of every
melanoma diagnosed before the age
of 18 at UCSF, and our data together
with other published series allowed
us to make some clinically important
observations.
One of the things we learned is
that E is the most predictive criterion.
Persistent lesions that are evolving or
changing should be approached with
a higher degree of suspicion. The
study supported the need for raised
awareness for melanoma in children
with lesions that are amelanotic, or
bleeding, and even those that are
uniform in color and of small diameter [<6mm].
The most important lesson we
learned in that study was that the
presentations of melanoma are vastly
different in prepubertal patients. That
age group requires a higher index of
suspicion for lesions with these atypical presentations.
As far as the eczema coxsackium
paper5, I have to give 100% of the
credit to my colleague and friend
[Dr.] Erin Mathes, who is a pediatric
dermatologist at UCSF. Dr. Mathes,
one of our fellows Dr. Vikash Oza,
and Dr. Frieden really spearheaded
that work. We were observing these
variant hand-foot-mouth disease
(HFMD) presentations and there
had been some reports coming out
of other countries around the same
time. I take really little to no credit for
that paper other than contributing a
few cases, reviewing, and helping to
edit the final product. I think it was
a very important paper that we all
learned from. The CVA6-associated
enterovirus outbreak was responsible
for an exanthem potentially more
widespread, severe, and varied than
classic HFMD that could be confused
with bullous impetigo, eczema herpeticum, vasculitis, and primary immunobullous disease.
DR. SIEGFRIED: What do you enjoy the most, what
takes most of your time? Is it patient care,
teaching, research?
A Dr. Cordoro: I love that you asked
me that question. It’s patient care.
I am first and foremost a clinician,
and I’m happiest when I am behind
a closed door with a complicated
patient. The bonus is, I’m in an academic environment where my passion for teaching is married to patient
care. Every patient I see presents a
learning opportunity for our trainees
and for me.
DR. SIEGFRIED: I know you’re working a lot on
psoriasis. Is there anything else that’s really
exciting you and making you enthusiastic?
A Dr. Cordoro: Psoriasis is probably
my favorite disease. I am working with the Pediatric Dermatology
Research Alliance (PeDRA). We have
a psoriasis investigator group, and
TAKEAWAY see page 96
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mid-town Manhattan. Includes SmartLipo,
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Cellulaze, and over 40 lasers and EBD’s
t 'VMMUJNFo'U.ZFST'-
as well as exposure to plastic surgery
t 'VMMUJNFo1FUPTLFZ.*
procedures such as blepharoplasty, etc.
t 'VMMUJNFo"MCBOZ("
Email CV to: [email protected]
MEDICAL DERMATOLOGY
FELLOWSHIP
1 – 2 years experience in management of
complex medical dermatology patients in both
private practice & teaching clinic.
t 'VMMUJNF$FOUFSWJMMF0)
t 'VMMUJNF1IJMBEFMQIJB1"
t 1BSUUJNF4QBSUBOCVSH4$
t 'VMMUJNFo5SBWFSTF$JUZ.*
For immediate consideration,
TFOEZPVS$7UPEBZ
* Multiple offices and Dermatologists
feed into the Mohs surgery schedule
4VCNJU$7UP
Christie Knowles at [email protected]
PSDBMM
Dr. Matt Leavitt, Founder & CEO
Biologics, immunsuppressants,
immunomodulators, clinical trials. PGY 5/6.
Send CV & 2 LOR to:
David Fivenson, MD.
²YHQVRQGHUPDWRORJ\#FRPFDVWQHW
COLORADO
BOULDER, COLORADO
WATERBURY, CONNECTICUT
NATIONAL
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
MOHS SURGEON
MULTIPLE PART TIME OPPORTUNITIES
Montrose, CO
Enfield, CT
Groton, CT
Reno, NV
Hickory, NC
Sanford, NC
Bountiful, UT
Tampa, FL
Calumet City, IL
1-2 days/mo
2-3 days/mo
1-2 days/mo
1-2 days/mo
1-2 days/mo
2-3 days/mo
3-4 days/mo
1-2 days/mo
1-2 days/mo
MONTROSE, COLORADO
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
CONNECTICUT
DISTRICT OF COLUMBIA
WASHINGTON, DC
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
CONNECTICUT
FLORIDA
ARIZONA
Well Established, busy General/Surgical/
MOHS Dermatology practice in
Phoenix, AZ area looking for a caring
and ambitious BE/BC dermatologist
for General/Surgical dermatology.
Full or Part time - Great earning potential
Please email C-V to: [email protected]
CALIFORNIA
GROTON, CONNECTICUT
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
TAMPA, FLORIDA
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
SOUTHBURY, CONNECTICUT
WEST PALM BEACH, FLORIDA
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
PORTERVILLE, CALIFORNIA
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
A D V E R T I S E T O D AY !
93
94
Marketplace
Dermatology Times |
September 2015
CAREERS
FLORIDA
ILLINOIS
START A NEW PRACTICE IN MIAMI BEACH!
CALUMET CITY/DYER, IN
Busy Derm office seeking FT or PT Dermatologist
t Job available immediately
t Stable long term position
t Salary negotiable
Please email resume to [email protected]
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
MASSACHUSETTS
HAWAII
MediSpa Hawaii needs a
DERMATOLOGIST
(Medical and Cosmetic)
Needed in 5 locations in the Pacific
Coastal Massachusetts
DERMATOLOGIST
Large, multispecialty practice located in North Dartmouth, MA is a seeking
to add another BC/BE dermatologist. One year to full partnership. Current
dermatologist earning $450K+ working three days per week doing only
medical and surgical dermatology.
) Pearl City
) Honolulu
) Hilo
) Kona
) Guam
Profit share of 45% for you,
entrepreneurial.
Send CV to
[email protected]
or call 808 485 1122
Interested candidates email to: [email protected]
MONTANA
MASSACHUSETTS
WORCESTER, MASSACHUSETTS
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
Join our team in bettering the lives of our patients –
exciting opportunity located in beautiful Big Sky Country - Billings, Montana
DERMATOLOGIST
St. Vincent Healthcare in Billings, Montana seeks U.S. trained $'$%EGTVKƂGF
physician for our Dermatology & Skin Cancer Center.
U Full time employed position.
U Dermatopathologist in house.
U St. Vincent Healthcare’s laboratory is accredited by the College of American
Pathologists (CAP) and our cancer program is recognized by the Commission on
Cancer (CoC) as an Approved Cancer Program.
U Full complement of medical specialties available.
U Thriving medical community in a family-oriented suburban location.
U čLÕ`>ÌÀiVÀi>Ì>>VÌÛÌiÃÞi>ÀÀÕ`q}]Ã}]wÃ}]L}>`V>
«}°
U Competitive salaries with productivity incentives.
U Start date bonus, Moving Allowances and CME reimbursement.
For more information, please contact a physician recruiter:
NEW MEXICO
SANTA FE, NEW MEXICO
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
NEW YORK
BUFFALO, NEW YORK
Associate Opportunity
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
%CTTKG$CNNCTF at (406) 237-4002 or [email protected]
Therese Teske at (406) 237-4017 or [email protected]
RECRUITMENT ADVERTISING
Can Work For You! Reach highly-targeted, market-specific business
professionals, industry experts and prospects by placing your ad here!
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)1%-0':()612=1$KQEMPGSQ
September 2015
|
Marketplace
DermatologyTimes.com
CAREERS
NORTH CAROLINA
OREGON
HICKORY, NC
EUGENE, OREGON
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
OKLAHOMA
Part Time/Full Time Position
General/Cosmetic/Surgical
Dermatology
Spectacular Scenic Beauty
Excellent Benefits
Fax CV & Cover Letter to
541-683-5206 Or Call 541-681-5090
TEXAS
EAST TEXAS
Tulsa, Oklahoma
Premier Dermatology Practice
The Skin Cancer Center at the Tulsa
Cancer Institute is seeking a Board
Certified/Eligible Dermatologist to add
to its practice of cutaneous oncology.
Expertise and interest in melanoma
and Mohs surgery required.
Established Practice – 40 Yrs.
BC/BE Dermatologist PT/FT
The Tulsa Cancer Institute is the largest
physician-owned oncology network in
the state offering services at five cancer
centers throughout Oklahoma with
board certified physicians specializing in
Medical Oncology, Radiation Oncology,
Gyn-Oncology, and Dermatology/
Mohs Surgery.
Excellent opportunity to join a patient
centered practice in a collegial clinical
atmosphere with academic and
research opportunities as well as
housed in a state of the art facility.
Benefits include base salary guarantee
with production bonus, health insurance,
vacation/CME and the opportunity for
partnership in 2 years.
For further information contact:
Edward H. Yob, DO at
[email protected] or
call 918-307-0215
Excellent Benefits & Growth Potential
Clinical Analysis for Today’s Skincare Specialists
Content
Licensing for
Every
Marketing
Strategy
Medical, Surgical, Cosmetic
Mohs Surgery
Send Cover Letter and CV to:
Marketing solutions
[email protected]
Contact (214) 862-0017
UTAH
BOUNTIFUL, UTAH
Associate to Partner Opportunity.
Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
VIRGINIA
FREDERICKSBURG, VIRGINIA
Partnership available. Established practice.
Contact Karey, (866) 488-4100 or
www.MyDermGroup.com
fit for:
Outdoor | Direct Mail
Print Advertising
Tradeshow/POP Displays
Social Media
Radio & TV
Leverage branded
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RECRUITMENT ADVERTISING
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For information, call
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or visit our website at
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95
96 THE
TAKEAWAY
®
SEPTEMBER 2015 ⁄ DERMATOLOGYTIMES.COM
TAKEAWAY:
Risk stratification and procedural dermatology from page 88
we’re composing a survey to determine
current management patterns for pediatric psoriasis in the United States
[The MAPP US Study: Management
Approaches to Pediatric Psoriasis in the
United States], because we assume that
there’s a huge divergence in the way
patients are approached in this country
and among clinicians in other countries. We’ll extend the survey to Canada
as well. We’re trying to gather data to
inform future research and move us
closer to achieving consensus in the
area of management and risk stratification for purposes of evaluating children
with psoriasis for comorbidities.
Of course psoriasis projects are
always hot on the front burner. Other
projects at the moment include a
study exploring refractory pediatric
lupus panniculitis (LEP). Most of the
published articles about lupus panniculitis indicate that pediatric patients
get better with hydroxychloroquine
(Plaquenil), rarely requiring additional
medications. My experience with three
or four patients with severe, refractory,
disfiguring disease on massive systemic
immunosuppression prompted further
investigation. Other than those cases
ultimately diagnosed with subcutaneous panniculitis-like T cell lymphoma,
there is not much published about refractory LEP.
My other passion is procedural
dermatology. I enjoy an active laser
practice and we are putting together
our experience using the long-pulsed
Nd:YAG laser to treat pediatric vascular malformations such as glomuvenous and venous malformations.
There are gaps in the pediatric procedural literature and based on years
of practice, we are looking forward to
being able to make a contribution in
this area. DT
REFERENCES
1. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic
dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J
Am Acad Dermatol. 2014;71(2):327-49. https://
www.aad.org/education/clinical-guidelines
2. Marqueling AL, Cordoro KM. Systemic treatments for severe pediatric psoriasis: a practical
approach. Dermatol Clin. 2013;31(2):267-88.
3. Paller AS, Siegfried EC, Langley RG, et al.
Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med.
2008;358(3):241-51.
4. Cordoro KM, Gupta D, Frieden IJ, Mccalmont
T, Kashani-sabet M. Pediatric melanoma: results of a large cohort study and proposal for
modified ABCD detection criteria for children.
J Am Acad Dermatol. 2013;68(6):913-25.
5. Mathes EF, Oza V, Frieden IJ, et al. “Eczema
coxsackium” and unusual cutaneous findings in an enterovirus outbreak. Pediatrics.
2013;132(1):e149-57.
CHICAGO
2015 ASDS ANNUAL MEE TING
OC TOBER 15-18
The premier educational experience for
dermatologists committed to excellence in
cosmetic, Mohs, reconstructive and general
dermatologic surgery procedures.
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IMPORTANT INFORMATION ABOUT
EPIDUO® FORTE
(adapalene and benzoyl peroxide) GEL, 0.3% / 2.5%
BRIEF SUMMARY
This summary contains important information about EPIDUO FORTE
(Ep-E-Do-Oh For-Tay) Gel. It is not meant to take the place of your doctor’s
instructions. Read this information carefully before you start using EPIDUO
FORTE Gel. Ask your doctor or pharmacist if you do not understand any
of this information or if you want to know more about EPIDUO FORTE Gel.
For full Prescribing Information and Patient Information, please see the
package insert.
WHAT IS EPIDUO FORTE GEL?
EPIDUO FORTE Gel is a prescription medicine used on the skin (topical)
to treat acne vulgaris. Acne vulgaris is a condition in which the skin has
blackheads, whiteheads and pimples.
WHO IS EPIDUO FORTE GEL FOR?
EPIDUO FORTE Gel is for use in people 12 years of age and older. It is not
known if EPIDUO FORTE Gel is safe and effective for children younger than
12 years old.
Do not use EPIDUO FORTE Gel for a condition for which it was not
prescribed. Do not give EPIDUO FORTE Gel to other people, even if they
have the same symptoms you have. It may harm them.
WHAT SHOULD I TELL MY DOCTOR BEFORE USING
EPIDUO FORTE GEL?
Before you use EPIDUO FORTE Gel, tell your doctor if you:
B have other skin problems, including cuts or sunburn.
B have any other medical conditions.
B are pregnant or planning to become pregnant. It is not known if
EPIDUO FORTE Gel can harm your unborn baby. Talk to your doctor
if you are pregnant or planning to become pregnant.
B are breastfeeding or plan to breastfeed. It is not known if EPIDUO
FORTE Gel passes into your breast milk and if it can harm your
baby. Talk to your doctor about the best way to feed your baby if
you use EPIDUO FORTE Gel.
Tell your doctor about all of the medicines you take, including
prescription and over-the-counter medicines, vitamins and herbal
supplements. Using other topical acne products may increase the
irritation of your skin when used with EPIDUO FORTE Gel.
WHAT SHOULD I AVOID WHILE USING EPIDUO FORTE GEL?
B You should avoid spending time in sunlight or artificial sunlight,
such as tanning beds or sunlamps. EPIDUO FORTE Gel can make
your skin sensitive to sun and the light from tanning beds and
sunlamps. You should use sunscreen and wear a hat and clothes
that cover the areas treated with EPIDUO FORTE Gel if you have to
be in the sunlight.
B You should avoid weather extremes such as wind and cold as this
may cause irritation to your skin.
B You should avoid applying EPIDUO FORTE Gel to cuts, abrasions
and sunburned skin.
B You should avoid skin products that may dry or irritate your skin
such as medicated or harsh soaps, astringents, cosmetics that have
strong skin drying effects and products containing high levels of
alcohol, spices or limes.
B You should avoid the use of “waxing” as a hair removal method
on skin treated with EPIDUO FORTE Gel.
B EPIDUO FORTE Gel may bleach your clothes or hair.
Allow EPIDUO FORTE Gel to dry completely before dressing to
prevent bleaching of your clothes.
WHAT ARE THE MOST COMMON SIDE EFFECTS OF
EPIDUO FORTE GEL?
EPIDUO FORTE Gel may cause serious side effects including:
B Local skin reactions. Local skin reactions are most likely to happen
during the first 4 weeks of treatment and usually lessen with
continued use of EPIDUO FORTE Gel. Signs and symptoms of
local skin reaction include:
B Redness
B Dryness
B Scaling
B Stinging or burning
Tell your doctor right away if these side effects continue for longer than 4
weeks or get worse; you may have to stop using EPIDUO FORTE Gel.
These are not all of the possible side effects of EPIDUO FORTE Gel. For
more information, ask your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to
the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also
contact GALDERMA LABORATORIES, L.P. at 1-866-735-4137.
HOW SHOULD I USE EPIDUO FORTE GEL?
B Use EPIDUO FORTE Gel exactly as your doctor tells you to use it.
EPIDUO FORTE Gel is for use on the skin only (topical). Do not use
EPIDUO FORTE Gel in or on your mouth, eyes or vagina.
B Apply EPIDUO FORTE Gel 1 time a day.
B Do not use more EPIDUO FORTE Gel than you need to cover the
treatment area. Using too much EPIDUO FORTE Gel or using it more
than 1 time a day may increase your chance of skin irritation.
APPLYING EPIDUO FORTE GEL:
B Wash the area where the Gel will be applied with a mild or soapless
cleanser and pat dry.
B EPIDUO FORTE Gel comes in a pump. Depress the pump to dispense
a small amount (about the size of a pea) of EPIDUO FORTE Gel and
spread a thin layer over the affected area.
B Wash your hands after applying the Gel.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT
EPIDUO FORTE GEL?
B Talk to your doctor or pharmacist.
B Go to www.EPIDUOFORTE.com or call 1-866-735-4137.
All trademarks are the property of their respective owners.
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA
Revised: July 2015
20089-0415-BS
Reference: 1. Epiduo Forte Clinical Study Report (SRE 18240). Data on file.
Galderma Laboratories, L.P.
©2015 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
EPI-00007 Printed in USA 07/15
www.epiduoforte.com/hcp
PRESCRIBE EPIDUO FORTE GEL FOR POWERFUL CONTROL OF MODERATE TO SEVERE ACNE