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Supplement 1
Vol. 32, No. 2S
June 2013
A CME-certified Supplement to
Seminars in
Cutaneous
Medicine
and Surgery
Editors
Kenneth A. Arndt, MD
Philip E. LeBoit, MD
Bruce U. Wintroub, MD
Update on
Onychomycosis:
Effective Strategies
for Diagnosis
and Treatment
Guest Editors
David Pariser, MD
Boni Elewski, MD
Phoebe Rich, MD
Richard K. Scher, MD
Update on Onychomycosis: Effective Strategies for Diagnosis and Treatment
Original Release Date: June 2013
Most Recent Review Date: June 2013
Expiration Date: June 30, 2015
Estimated Time to Complete Activity: 2.5 hours
Medium or Combination of Media Used: Written Supplement
Method of Physician Participation: Journal Supplement
Hardware/Software Requirements:
High Speed Internet Connection
To get instant CME credits online, go to http://uofl.me/onycho13.
Upon successful completion of the online test and evaluation
form, you will be directed to a webpage that will allow you
to receive your certificate of credit via e-mail. Please add
[email protected] to your e-mail “safe” list. If you have
any questions or difficulties, please contact the University of
Louisville School of Medicine Continuing Medical Education
(CME & PD) office at [email protected].
Joint Sponsorship
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation
Council for Continuing Medical Education (ACCME) through
the joint sponsorship of the University of Louisville School of
Medicine and Global Academy for Medical Education, LLC.
The University of Louisville School of Medicine is accredited by
the ACCME to provide continuing education for physicians.
Designation Statement
The University of Louisville Continuing Medical Education
designates this enduring material for a maximum of 2.5 AMA
PRA Category 1 Credit(s)™. Physicians should claim only the
credit commensurate with the extent of their participation in
the activity.
Educational Needs
Onychomycosis has become recognized as an infection
of clinical importance well beyond its cosmetic effects. This
is especially true for elderly individuals, patients who are
immunocompromised (eg, because of post-transplant immunosuppressive drug therapy or HIV infection), and those with
diabetes. The number of patients who present with onychomycosis has grown substantially as these high-risk populations
increase, with increased longevity, greater survival among
people with HIV infections, and the growing prevalence of
diabetes mellitus. Clinicians must be prepared to make a
clinical diagnosis of onychomycosis based on physical examination and personal and family history. The current standard
of care is definitive diagnosis using recognized laboratory
methods for identifying the presence of causative organisms.
This supplement provides up-to-date information on epidemiology, pathophysiology, and diagnosis of onychomycosis,
and reviews and provides expert recommendations on the
currently available systemic and topical medications and
devices for treating this infection.
Learning Objectives
After participating in this continuing medical educational
activity, clinicians should be able to:
• List and describe the differential diagnosis of onychomycosis
and the expert-recommended methods for establishing the
diagnosis of this infection.
• Explain the benefits of early diagnosis and treatment of
onychomycosis and the potential sequelae if this infection
is untreated or is inadequately treated.
• Apply practice protocols for identifying patients with onychomycosis, particularly the elderly, patients with diabetes mellitus,
and other high-risk populations.
• Integrate effective, office-based diagnostic tests into the
workup of patients with symptoms of onychomycosis.
• Use currently available oral and topical medications to
treat various patient populations.
• Evaluate the results of clinical studies on new and emerging
treatments for onychomycosis.
Target Audience
This continuing medical education activity has been developed for dermatologists, family practice and internal medicine
physicians, and other health care providers who treat diseases
of the skin.
Disclosure
As a sponsor accredited by the ACCME, the University of
Louisville School of Medicine must ensure balance, independence, objectivity, and scientific rigor in all its sponsored
educational activities. All faculty participating in this CME
activity were asked to disclose the following:
1.Names of proprietary entities producing health care goods
or services—with the exemption of nonprofit or government
organizations and non–health-related companies—with
which they or their spouse/partner have, or have had, a
relevant financial relationship within the past 12 months.
For this purpose, we consider the relevant financial
relationships of a spouse/partner of which they are aware
to be their financial relationships.
2.Describe what they or their spouse/partner received
(eg, salary, honorarium).
3.Describe their role.
4.No relevant financial relationships.
CME & PD Advisory Board Members: have no relevant financial relationships with any commercial interests: Lisa J. Pfitzer,
MD; Soon Bahrami, MD; Douglas Coldwell, MD, PhD; W. Daniel
Cogan, Ed.D., FAODME; Justin L. Costa, MD; James Creg; Daniel
Da Justa, MD; Adair Heyl, PhD; Christopher Jones, MD;Lucy Juett,
MS; Gerald Larson, MD; Rana Latif, MD; Kimberly Moore; Karen
Napolilli; Scott Plantz, MD;Kerri Remmel, MD, PhD; Michael D.
Stillman, MD; Uldis Streips, PhD; Kathy M. Vincent, MD; Lori Wagner,
MD; Angela Wetherton, MD; and Stephen Wheeler, MD have no
relevant financial relationships with any commercial interests.
CME Reviewer: Timothy Brown, MD, Professor, Division of
Dermatology, University of Louisville, School of Medicine has no
relevant financial relationships with any commercial interests.
Boni Elewski, MD, has been an investigator for Anacor and
Valeant Pharmaceuticals.
David Pariser, MD, has been a consultant and/or investigator
and/or advisory board member with Abbott Laboratories,
Amgen, Astellas Pharma US, Inc, Basilea, Celgene Corporation,
Dow Pharmaceutical Sciences, Inc., DUSA Pharmaceuticals, Inc.,
Eli Lily and Company, Galderma Laboratories, L.P., Genentech,
Inc., Graceway Pharmaceuticals, LLC, Intendis, Inc., JanssenOrtho Inc, Johnson & Johnson Consumer Products Company,
LEO Pharma, US, Medicis Pharmaceutical Corporation,
MelaSciences, Novartis Pharmaceutical Corporation, Novo
Nordisk A/S, Ortho Dermatologics, Peplin Inc., Pfizer, Photocure
ASA, Proctor & Gamble Company, Stiefel a GSK company, and
Valeant Pharmaceuticals International.
Phoebe Rich, MD, has been a principal investigator and/or
consultant for Valeant, Dow Pharmaceuticals, Topica, and Tolmar.
Richard K. Scher, MD, is an advisor/consultant to Valeant.
Joanne Still, BA has no relevant financial relationships with
any commercial interests.
Sylvia H. Reitman, MBA and Shirley V. Jones, MBA, Global
Academy for Medical Education, have no relevant financial
relationships with any commercial interests.
Acknowledgments
The authors would like to thank Global Academy for Medical
Education and Joanne Still for assistance with the preparation
of this supplement.
This activity is supported by an educational grant from Medicis,
a division of Valeant Pharmaceuticals.
University of Louisville CME & PD Privacy Policy
All information provided by course participants is confidential
and will not be shared with any other parties for any reason
without permission.
Seminars in
Cutaneous Medicine
and Surgery
Editors
Kenneth A. Arndt, MD
Clinical Professor of Dermatology, Emeritus
Harvard Medical School
Boston, Massachusetts
Adjunct Professor of Surgery
Dartmouth Medical School
Hanover, New Hampshire
Adjunct Professor of Dermatology
Brown Medical School
Providence, Rhode Island
Philip E. LeBoit, MD
Professor of Clinical Dermatology
University of California San Francisco
San Francisco, California
Bruce U. Wintroub, MD
Associate Dean
Professor and Chair of Dermatology
School of Medicine
University of California San Francisco
San Francisco, California
Statement
of Purpose
Seminars in Cutaneous Medicine and Surgery presents well-rounded and authoritative discussions of
important clinical areas, especially those undergoing rapid change in the specialty. Each issue, under the
direction of the Editors and Guest Editors selected because of their expertise in the subject area, includes
the most current information on the diagnosis and management of specific disorders of the skin, as well
as the application of the latest scientific findings to patient care.
Guest Editors
David Pariser, MD, Chair
Professor of Dermatology
Eastern Virginia Medical School
Department of Dermatology
Pariser Dermatology
Norfolk, Virginia
Boni Elewski, MD
Vice-Chair for Clinical Affairs
Professor of Dermatology
University of Alabama School of Medicine
Birmingham, Alabama
Phoebe Rich, MD
Clinical Adjunct Professor of Dermatology
Oregon Health Science University
Portland, Oregon
Richard K. Scher, MD
Clinical Professor of Dermatology
Weill Cornell Medical College
New York, New York
The Guest Editors acknowledge the editorial assistance of Global Academy for Medical Education, LLC,
and Joanne Still, medical writer, in the development of this supplement.
This continuing medical education (CME) supplement was developed from a clinical roundtable.
The manuscript was reviewed and approved by the Guest Editors as well as the Editors of Seminars
in Cutaneous Medicine and Surgery. The ideas and opinions expressed in this supplement are those of
the Guest Editors and do not necessarily reflect the views of the supporter or of the Publisher.
This educational supplement is supported by
Jointly sponsored by
and
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Editors
Kenneth A. Arndt, MD
Philip E. LeBoit, MD
Bruce U. Wintroub, MD
Publication of an advertisement in Seminars in Cutaneous Medicine and Surgery does not imply endorsement of its
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a publication by IMNG Medical Media, a division
of Frontline Medical Communications Inc.
Seminars in
Cutaneous Medicine
and Surgery
Volume 32
Number 2S
Update on Onychomycosis:
Effective Strategies for
Diagnosis and Treatment
S1 The Rationale for Renewed Attention to Onychomycosis
David Pariser
S2 The Epidemiology, Etiology, and Pathophysiology
of Onychomycosis
Richard K. Scher, Phoebe Rich, David Pariser and Boni Elewski
S5 Diagnosis, Clinical Implications, and Complications
of Onychomycosis
Phoebe Rich, Boni Elewski, Richard K. Scher and David Pariser
S9 Current and Emerging Options in the Treatment
of Onychomycosis
Boni Elewski, David Pariser, Phoebe Rich and Richard K. Scher
S13 Promoting and Maintaining or Restoring Healthy Nails:
Practical Recommendations for Clinicians and Patients
David Pariser, Richard K. Scher, Boni Elewski and Phoebe Rich
a publication by IMNG Medical Media, a division
of Frontline Medical Communications Inc.
Volume 32, Number 2S
June 2013
The Rationale for Renewed Attention to Onychomycosis
David Pariser, MD
O
nychomycosis is a common problem that the average
dermatologic practitioner encounters every day. Our
experiences with this infection are as varied as the patients
who present with onychomycosis.
All clinicians certainly have encountered patients with very
mild, asymptomatic cases of onychomycosis of the toenails,
about which the patient expresses little or no interest in treatment. Even those whose infection has progressed to yellowing,
brittleness, and lifting of the nail plate in several toes may
mention the condition inside their shoes only as an afterthought in a medical encounter for a different complaint.
Patients who do seek medical attention for onychomycosis as
their primary complaint usually do so because of one or more
of the following: pain and discomfort, a secondary infection
of the skin around the nail plate, unsightly appearance, or
interference with normal function. Other patients come to
the attention of clinicians because their nail disease is associated with other systemic diseases.
Few in our specialty today would consider the infection too
trivial to treat, even in cases in which the clinical manifestations are, to all appearances, mainly cosmetic. Onychomycosis
often is a progressive condition that warrants intervention.
Clinical Sequelae
The understanding of nail disease as an important medical
condition is a relatively recent development. As Richard K.
Scher, MD, noted in an editorial, “Nail disorders—One of
dermatology’s last frontiers,” few articles appeared in the
literature on this topic until the 1980s.1 This lack of attention
can be attributed in part to underappreciation of the importance of infections of the nail and in part to the dearth of
available effective modalities to treat these conditions.
Publication of this CME article was jointly sponsored by the University
of Louisville School of Medicine Continuing Medical Education and
Global Academy for Medical Education, LLC and is supported by an
educational grant from Medicis, a division of Valeant Pharmaceuticals.
Dr Pariser has been a consultant and/or investigator and/or advisory board
member with Abbott Laboratories, Amgen, Astellas Pharma US, Inc,
Basilea, Celgene Corporation, Dow Pharmaceutical Sciences, Inc., DUSA
Pharmaceuticals, Inc., Eli Lily and Company, Galderma Laboratories, L.P.,
Genentech, Inc., Graceway Pharmaceuticals, LLC, Intendis, Inc., JanssenOrtho Inc, Johnson & Johnson Consumer Products Company, LEO
Pharma, US, Medicis Pharmaceutical Corporation, MelaSciences, Novartis
Pharmaceutical Corporation, Novo Nordisk A/S, Ortho Dermatologics,
Peplin Inc., Pfizer, Photocure ASA, Proctor & Gamble Company, Stiefel
a GSK company, and Valeant Pharmaceuticals International.
David Pariser, MD, has received an honorarium from Global Academy for
Medical Education for his participation in this activity. He acknowledges
the editorial assistance of Joanne Still, medical writer, and Global
Academy for Medical Education in the development of this continuing
medical education journal article. Joanne Still has no relevant financial
relationships with any commercial interests.
1058/5629/13/$-see front matter © Frontline Medical Communications
http://dx.doi.org/10.12788/j.sder.0013
The consequences of failure to treat include permanent
damage to the nail plate and its attachments, the development of secondary infections with bacteria and other
organisms, local spread of the infection (paronychia) or
spread to other parts of the body, and transmission of the
infection to others.2 For example, Trichophyton rubrum—the
most common causative organism of both onychomycosis
and tinea pedis—can be transmitted to the groin area as
individuals step into and pull clothing up the legs. In addition, minor wounds on the legs may be colonized by fungal
organisms in this manner, and secondary bacterial infections and cellulitis may result.
In addition, in elderly patients—in whom onychomycosis
is highly prevalent—the infection may complicate any existing foot problems and may lead to decreased mobility.2 Any
alterations in normal gait represent an increased risk for
falls, and as the population continues to age—and as older
persons live longer—both the individual and public health
consequences are evident.
The adverse effects of onychomycosis on quality of life
also must be considered. In addition to embarrassment and
self-consciousness, untreated or ineffectively treated onychomycosis often interferes with social interactions
(particularly intimate relationships) because of fear of contagion. Furthermore, adverse effects on job function or on
new or continued employment is possible when onychomycosis of the toenails affects mobility and when infections of
the fingernails interfere with a job that involves direct
contact with the public (such as restaurant wait staff, health
care workers, and retail sales).
Clearly, onychomycosis is an infectious disease of significant importance.
Conclusion
Clinicians need to know about how onychomycosis presents
clinically, how to make a definitive diagnosis (which involves
identifying the causative organism in each patient prior to
initiating therapy), which treatments currently are available
and how best to use them, and which new agents are now in
clinical trials and may soon be options for therapy.
The purpose of the articles in this supplement is to offer
a convenient compendium of current information in all of
these areas for both clinician and patient.
References
1. Scher RK. Nail disorders—One of dermatology’s last frontiers. Dermatol Ther.
2007;20:1-2.
2. Scher RK. Onychomycosis: A significant medical disorder. J Am Acad Dermatol.
1996;35:S2-S5.
S1
The Epidemiology, Etiology, and
Pathophysiology of Onychomycosis
Richard K. Scher, MD,* Phoebe Rich, MD,† David Pariser, MD,‡ Boni Elewski, MD§
ABSTRACT The prevalence of onychomycosis in the United States is estimated to be at least 12%;
prevalence increases with increasing age and is highest in individuals more than 65 years
of age. Trichophyton rubrum, which also causes tinea pedis, is responsible for approximately
90% of cases of toenail onychomycosis. Risk factors include a family history of onychomycosis and previous injury to the nails, as well as advanced age and compromised
peripheral circulation. Patients with compromised immune function may have an increased
risk for onychomycosis and are susceptible to infection with less common dermatophytes
and nondermatophyte organisms.
Semin Cutan Med Surg 32(suppl):S2-S4 © 2013 published by Frontline Medical Communications
KEYWORDS fungal infections; nail infections; onychomycosis; Trichophyton rubrum
T
he reported prevalence of onychomycosis in the United
States varies considerably, as no scientifically rigorous,
large epidemiologic studies have been done to date. The
prevalence varies according to patient population (including
age, family history, comorbid conditions) and also depends
on variables such as geography and climate. The authors
concur that the median figure probably is 10% to 12% or
* Clinical Professor of Dermatology, Weill Cornell Medical College
New York, NY
†Clinical Adjunct Professor of Dermatology, Oregon Health Science
University, Portland, OR
‡Professor of Dermatology, Eastern Virginia Medical School
Department of Dermatology, Pariser Dermatology, Norfolk, VA
§Vice-Chair for Clinical Affairs, Professor of Dermatology
University of Alabama School of Medicine, Birmingham, AL
Publication of this CME article was jointly sponsored by the University
of Louisville School of Medicine Continuing Medical Education and
Global Academy for Medical Education, LLC and is supported by an
educational grant from Medicis, a division of Valeant Pharmaceuticals.
The faculty have received an honorarium from Global Academy for
Medical Education for their participation in this activity. They
acknowledge the editorial assistance of Joanne Still, medical writer,
and Global Academy for Medical Education in the development of this
continuing medical education journal article. Joanne Still has no
relevant financial relationships with any commercial interests.
Boni Elewski, MD, has been an investigator for Anacor and Valeant.
David Pariser, MD, has been a consultant and/or investigator and/or
advisory board member with Abbott Laboratories, Amgen, Astellas
Pharma US, Inc, Basilea, Celgene Corporation, Dow Pharmaceutical
Sciences, Inc., DUSA Pharmaceuticals, Inc., Eli Lily and Company,
Galderma Laboratories, L.P., Genentech, Inc., Graceway Pharmaceuticals,
LLC, Intendis, Inc., Janssen-Ortho Inc, Johnson & Johnson Consumer
Products Company, LEO Pharma, US, Medicis Pharmaceutical
Corporation, MelaSciences, Novartis Pharmaceutical Corporation, Novo
Nordisk A/S, Ortho Dermatologics, Peplin Inc., Pfizer, Photocure ASA,
Proctor & Gamble Company, Stiefel a GSK company, and Valeant
Pharmaceuticals International.
Phoebe Rich, MD, has been a principal investigator and/or consultant
for Valeant, Dow Pharmaceuticals, Topica, and Tolmar.
Richard K. Scher, MD, is an advisor/consultant to Valeant.
Address reprint requests to: Richard K. Scher, MD, Weill Cornell Center for
Dermatology. 1305 York Avenue and 70th Street, 9th Floor, New York, NY
10021, Telephone: (646) 962-3376, E-mail: [email protected]
S2
higher.1,2 However, it also should be noted that onychomycosis is rare in children (less than 1%)2 and increases in
prevalence with increasing age (the prevalence in the geriatric
population has been estimated at 60%).1
Etiology and Pathophysiology
The causative organisms in most cases of onychomycosis are dermatophytes. (The term “tinea unguium” often
is used interchangeably with onychomycosis; however,
tinea unguium applies only to cases of onychomycosis
caused by dermatophyte fungi.) Dermatophyte organisms
are ubiquitous and are found in soil (geophilic), animals
(zoophilic), and humans (anthropophilic). Species of three
genera are anthropophilic: Trichophyton, Microsporum, and
Epidermophyton. These are keratinophilic organisms, and, as
such, they invade keratinized tissues, including the stratum
corneum, the hair, and the nails.
The most common organisms found in onychomycosis
(Table on page S3) are Trichophyton rubrum, which is responsible for an estimated 90% of infections, and Trichophyton
mentagrophytes, which is implicated most commonly in the
balance of cases.1 Not surprisingly, onychomycosis of the
toenails typically occurs in individuals who have concurrent
tinea pedis infections (“athlete’s foot”), also caused by
T. rubrum. Microsporum spp and Epidermophyton floccosum
(the only Epidermophyton species found in humans) are
unusual causes of onychomycosis in the United States.
A number of other organisms also may be involved in nail
infections, including some yeasts—especially Candida spp,
which most commonly occur in fingernails and most often
are seen in tropical regions—and some nondermatophyte
molds (such as Fusarium and Aspergillus spp).1 Although
these occur much less frequently than do the dermatophyte
infections, it is important to be aware that yeasts and nondermatophyte molds may be present, particularly in certain
1058/5629/13/$-see front matter © Frontline Medical Communications
http://dx.doi.org/10.12788/j.sder.0014
The Epidemiology, Etiology, and Pathophysiology of Onychomycosis
S3
Table. Nail Infections in the United States: Causative Organisms1
Types of Organisms
Most Common
Less Common
Least Common
Dermatophytes
Trichophyton rubrum
Trichophyton mentagrophytes Trichophyton tonsurans
Microsporum canis
Epidermophyton floccosum
Nondermatophytes
Acremonium spp
Scopulariopsis spp
Fusarium spp
Scytalidium spp
Aspergillus versicolor
Aspergillus flavus
Aspergillus fumigatus
Aspergillus terreus
Yeasts
Candida parapsilosis
Candida albicans
Candida guilliermondii
Candida tropicalis
Candida lusitaniae
groups of patients (see the section, “Special Patient
Populations,” below). Candida spp and nondermatophyte
molds tend to be more difficult to treat effectively, and
earlier identification of these organisms and prompt initiation of therapy may improve outcomes.
Certain factors are known to increase the risk for developing onychomycosis. Individuals who perspire heavily or
whose occupations or recreational activities expose them to
humid, moist environments are at increased risk. In such
persons, footwear that crowds the toes or prevents adequate
air circulation—and, therefore, evaporation of excess moisture—compounds the problem.
Individuals with a previous history of nail injury or previous infection are particularly susceptible under these
conditions. Also, the risk for onychomycosis is increased
with participation in occupations, sports, or exercise in
which chronic minor trauma to the toes is sustained.
In addition, practices such as walking barefoot in public
places where moisture is an integral part of the environment
(eg, swimming pools, spas, gyms, locker rooms) are
common sources of transmission of causative organisms.3
Another frequent source of onychomycosis is nail salons;
disinfection regimens for clippers, scissors, and other instruments are not always effective (even if rigorously followed),
and emery boards retain dust from person to person and may
be a source of organism transmission.
Onychomycosis also is a topic of concern among several
special patient populations: individuals with compromised
peripheral circulation, the elderly, those with diabetes,
persons with a family history of onychomycosis, those with
compromised immune function, and possibly also patients
with psoriasis and pediatric patients.
Special Patient Populations
Compromised Peripheral Circulation
Impaired circulation from any cause—for example, diabetes,
vascular disease, or advanced age—is associated with an
increased risk for onychomycosis as well as with a diminished response to therapy. Poor circulation is associated with
a decrease in nail growth rate, which increases the risk for
colonization by dermatophytes and other organisms.4 Patients
with poor peripheral circulation may need higher dosages of
systemic medications and/or may require a longer course of
therapy than do individuals with good circulation.
Advanced Age
Onychomycosis is among the most common infections that
affect older individuals.5 Elewski and Charif6 report that
approximately 40% of elderly patients have onychomycosis.
The presence of arthritis and other conditions that affect
physical flexibility contributes to the increased prevalence of
onychomycosis in this population. Gait changes and circulatory problems contribute to the development of corns,
calluses, and bunions, and minor repeated trauma to the toes
is common. It is difficult for many older individuals to exercise careful hygiene of the feet and nails, increasing
susceptibility to colonization by infectious organisms.7
Many older patients have one or more conditions—such
as diabetes and peripheral vascular compromise—that
contribute to an increased risk for onychomycosis and can
represent potential impediments to a good therapeutic
response. As in patients with poor circulation, slower nail
growth increases the risk for onychomycosis in older individuals. The reduction in nail growth rate ranges from about
40% to 60% in persons more than 65 years of age; nail
growth can slow even more as age increases.8
Finally, slower drug metabolism, which occurs with
aging, may interfere with effective systemic therapy for
onychomycosis. In addition, many older patients take multiple medications, so the possibility of interactions with
systemic antifungal agents must be considered.
Diabetes
Some controversy exists as to whether individuals with diabetes are more susceptible to onychomycosis than are those
without diabetes and whether the treatment of those with
diabetes is more difficult than the treatment of those
without diabetes. Less debatable is the observation that
onychomycosis is more prevalent in patients with diabetes
than in patients without the condition. There is no question,
however, that onychomycosis makes patients with diabetes
more susceptible to secondary infection9,10 and that nail
infections contribute to the development of cellulitis and
S4
phlebitis. In addition, patients with diabetes tend to have
onychomycosis from atypical organisms,11 particularly
yeasts, than do those without diabetes, and infections with
these organisms often are more difficult to treat than are
those caused by dermatophytes.
Family History
Good evidence demonstrates that a family history of onychomycosis predisposes individuals to nail infection.12 It is likely
that a genetic predisposition exists, but it is also probable that
transmission of the causative organism(s) is increased among
family members living in the same household. For the same
reasons, a family history of onychomycosis is associated with
recurrence of nail infections after treatment and almost
always is associated with pediatric onychomycosis.
Compromised Immune Function
Immunocompromised patients can be problematic both in
terms of susceptibility and because they are susceptible to
invasion by less common organisms—that is, unusual
dermatophytes and nondermatophyte microbes.
Candida albicans, which is implicated predominantly in
fingernail infections, may be acquired by direct contact with
a lesion caused by the same organism. Interestingly, Candida
species do not produce the enzymes necessary to effectively
invade keratin in healthy individuals. It is seen primarily in
immunocompromised hosts who already have onycholysis,
which creates a warm, moist, dark environment underneath
the nail plates. It can also sometimes cause paronychia.
Individuals with HIV/AIDS also have a higher susceptibility and may have the proximal white subungual type of
onychomycosis.13 In addition, the number of medications
these patients must take on a daily basis makes the prescription of yet another systemic medication an issue to be
carefully considered.
Psoriasis
Nail psoriasis very closely resembles onychomycosis, particularly in toenails.14 Several studies have shown that in
almost 30% of individuals with psoriasis who have abnormal toenails, a dermatophyte organism can be cultured
from the nail. Treatment for onychomycosis in these cases
will clear the dermatophyte infection, but the portion of
the nail affected by psoriasis will not improve. About 5%
of patients have nail involvement as their initial presentation of psoriasis.14 Therefore, psoriasis should be
considered as a possible diagnosis—or concomitant diagnosis—in patients with onychomycosis.
Pediatric Patients
A prevailing myth from years past was that children do not
get onychomycosis. More recent observation and evidence
demonstrates that children do indeed acquire the infection;
the prevalence is very low, now estimated at less than
1%,1 although it may be increasing. In general, pediatric
patients who develop onychomycosis have a family history
of the infection. Therefore, an examination of the nails of
adolescent and adult family members is warranted whenever
a child presents with signs or symptoms of onychomycosis.
Systemic therapy for onychomycosis in children is not
approved by the US Food and Drug Administration,
although terbinafine, fluconazole, and itraconazole are used
commonly for treating fungal infections in pediatric
patients. Recently, Gupta and Paquet proposed dosing regimens, based on the patient’s weight, for children with either
fingernail or toenail onychomycosis.15
Conclusion
Onychomycosis is a common infection that requires appropriate diagnosis and treatment. In most patients, the
causative organism is a dermatophyte—usually T. rubrum—
that is readily and easily treatable. Patients in some special
populations are at higher risk for infections with nondermatophyte fungi and yeasts. Nail infections with these
organisms may have a protracted course and may be difficult to eradicate. Treatment in such patients may be
complicated by the presence of systemic illnesses that
require the use of multiple potent systemic medications.
References
1. Ghannoum MD, Hajjeh RA, Scher R. A large-scale North American study of
fungal isolates from nails: The frequency of onychomycosis, fungal distribution, and antifungal susceptibility patterns. J Am Acad Dermatol. 2000;43:
641-648.
2. Heikkilä H, Stubb S. The prevalence of onychomycosis in Finland. Br J Dermatol.
1995;133:699-703.
3. Pleacher MD, Dexter WW. Cutaneous fungal and viral infections in athletes.
Clin Sports Med. 2007;26:397-411.
4. Elewski BE. Onychomycosis: Pathogenesis, diagnosis, and management. Clin
Microbiol Rev. 1998;11:415-429.
5. Smith ES, Fleischer AB Jr, Feldman SR. Demographics of aging and skin
disease. Clin Geriatr Med. 2001;17:631-641.
6. Elewski B, Charif MA. Prevalence of onychomycosis in patients attending a
dermatology clinic in northeastern Ohio for other conditions. Arch Dermatol.
1997;133:1172-1173.
7. Htwe TH, Mushtaq A, Robinson SB, Rosher RB, Khardori N. Infection in the
elderly. Infect Dis Clin North Am. 2007;21:711-743.
8. Abdullah L, Abbas O. Common nail changes and disorders in older people:
Diagnosis and management. Can Fam Physician. 2011;57:173-181.
9. Tan JS, Joseph WS. Common fungal infections of the feet in patients with
diabetes mellitus. Drugs Aging. 2004;21:101-112.
10. Gupta S, Koirala J, Khardori R, Khardori N. Infections in diabetes mellitus and
hyperglycemia. Infect Dis Clin North Am. 2007;21:617-638.
11. Winston JA, Miller JL. Treatment of onychomycosis in diabetic patients. Clin
Diabetes. 2006;24:160-166.
12. Piraccini BM, Sisti A, Tosti A. Long-term follow-up of toenail onychomycosis
caused by dermatophytes after successful treatment with systemic antifungal
agents. J Am Acad Dermatol. 2010;62:411-414.
13. Gupta AK, Taborda P, Taborda V, et al. Epidemiology and prevalence of onychomycosis in HIV-positive individuals. Int J Dermatol. 2000;39:746-753.
14. Rich P, Griffiths CEM, Reich K, et al. Baseline nail disease in patients with
moderate to severe psoriasis and response to treatment with infliximab during
1 year. J Am Acad Dermatol. 2008;58:224-231.
15. Gupta A, Paquet M. Onychomycosis in children. J Am Acad Dermatol. 2012;
66(4 suppl 1):AB120.
Diagnosis, Clinical Implications, and
Complications of Onychomycosis
Phoebe Rich, MD,* Boni Elewski, MD,† Richard K. Scher, MD,‡ David Pariser, MD§
ABSTRACT The diagnosis of onychomycosis is suggested by the clinical presentation as well
as the family history and patient age. The definitive diagnosis of onychomycosis is based
on (1) establishing the presence or absence of fungal elements using laboratory methods
and/or (2) identifying the fungus using fungal culture or, in the future, by polymerase
chain reaction as new developments emerge in this technology, making more widespread
application of this technique possible.
Semin Cutan Med Surg 32(suppl):S5-S8 © 2013 published by Frontline Medical Communications
KEYWORDS fungal infections; nail infections; onychomycosis; potassium hydroxide preparations
O
nychomycosis is defined as a fungal infection of the nail
unit (Figure 1): the nail plate, nail bed, and periungual
tissue. The most common culprits in immunocompetent
patients are Trichophyton rubrum (90% of cases) and
Trichophyton mentagrophytes (most of the remaining 10% of
cases).1 Less commonly, yeasts and nondermatophyte molds
may be causative organisms, particularly in certain patient
*Clinical Adjunct Professor of Dermatology, Oregon Health Science
University, Portland, OR
†Vice-Chair for Clinical Affairs, Professor of Dermatology
University of Alabama School of Medicine, Birmingham, AL
‡Clinical Professor of Dermatology, Weill Cornell Medical College
New York, NY
§Professor of Dermatology, Eastern Virginia Medical School
Department of Dermatology, Pariser Dermatology, Norfolk, VA
Publication of this CME article was jointly sponsored by the University
of Louisville School of Medicine Continuing Medical Education and
Global Academy for Medical Education, LLC and is supported by an
educational grant from Medicis, a division of Valeant Pharmaceuticals.
The faculty have received an honorarium from Global Academy for
Medical Education for their participation in this activity. They
acknowledge the editorial assistance of Joanne Still, medical writer,
and Global Academy for Medical Education in the development of this
continuing medical education journal article. Joanne Still has no
relevant financial relationships with any commercial interests.
Boni Elewski, MD, has been an investigator for Anacor and Valeant.
David Pariser, MD, has been a consultant and/or investigator and/or
advisory board member with Abbott Laboratories, Amgen, Astellas
Pharma US, Inc, Basilea, Celgene Corporation, Dow Pharmaceutical
Sciences, Inc., DUSA Pharmaceuticals, Inc., Eli Lily and Company,
Galderma Laboratories, L.P., Genentech, Inc., Graceway Pharmaceuticals,
LLC, Intendis, Inc., Janssen-Ortho Inc, Johnson & Johnson Consumer
Products Company, LEO Pharma, US, Medicis Pharmaceutical
Corporation, MelaSciences, Novartis Pharmaceutical Corporation, Novo
Nordisk A/S, Ortho Dermatologics, Peplin Inc., Pfizer, Photocure ASA,
Proctor & Gamble Company, Stiefel a GSK company, and Valeant
Pharmaceuticals International.
Phoebe Rich, MD, has been a principal investigator and/or consultant
for Valeant, Dow Pharmaceuticals, Topica, and Tolmar.
Richard K. Scher, MD, is an advisor/consultant to Valeant.
Address reprint requests to: Phoebe Rich, MD, 2565 NW Lovejoy Street,
Suite 200, Portland, OR 97210, Telephone: (503) 226-3376, E-mail:
[email protected]
1058/5629/13/$-see front matter © Frontline Medical Communications
http://dx.doi.org/10.12788/j.sder.0015
populations, such as patients with diabetes, the elderly, and
immunocompromised individuals. (For further discussion
in this supplement, see Scher et al.2) Onychomycosis caused
by dermatophytes is significantly more common in toenails
than in fingernails; the opposite is true of Candida infections, which are significantly more common in fingernails
than in toenails.3
Nail Plate
Side View
Proximal Nail Fold
Eponychium
True Cuticle
Lunuta
Distal Edge
Nail Bed
Onychocomeal/
Onychodermal Band
Hyponychium
Nail Plate
Lunuta
Lateral
Nail Fold
Surface View
Eponychium/
Cuticle
Proximal Nail Fold
Figure 1. Nail Anatomy The nail plate (consisting of keratin) forms in the matrix
and is attached to the nail bed as it grows. Although the distal portion of the matrix
is typically visible (as the lunula) in the thumb and forefinger, it is concealed under
the proximal nail fold in the rest of the fingers and the toes. The proximal nail fold
covers and adheres to the base of the nail; the distal portion of the proximal fold
is the cuticle. Lateral nail folds form soft tissue boundaries at the sides of the nails.
Physical Examination
The physical examination should include careful inspection
of all fingernails and toenails. The extent of involvement
(the number of nails and the percentage of involvement of
each nail unit) should be noted.
S5
S6
Figure 2. Distal-lateral-subungual onychomycosis. Note the onycholysis, along with
thickening, crumbling, and discoloration of the nail plate and subungual debris.
Photo courtesy of Phoebe Rich, MD.
Figure 4. Superficial white onychomycosis. Leuconychia and crumbling, as seen in
this patient, is a result of direct invasion of the nail plate surface. Photo courtesy of
Phoebe Rich, MD.
Figure 3. Proximal subungual onychomycosis. Proximal subungual onychomycosis.
Figure 5. Candidal onychomycosis.Onycholysis and chronic paronychia may result
This presentation is marked by invasion of the proximal nail bed via the cuticle. It is
unusual in immunocompetent patients. Photo courtesy of Antonella Tosti, MD, Professor
of Dermatology, Department of Dermatology and Cutaneous Surgery, University of Miami,
Leonard M Miller School of Medicine.
from invasion of Candida. In immunocompetent patients, this is secondary to other
causes such as trauma or chronic exposure to water. Photo courtesy of Phoebe Rich, MD.
The clinical features of onychomycosis (Table 1) include
nail bed hyperkeratosis with subsequent separation of the
nail plate from the nail bed (onycholysis), the presence of
subungual debris, and nail plate dyschromia. Individuals
with onychomycosis also may experience associated
inflammation and tenderness of the nail bed or periungual tissue. Concomitant tinea pedis infection (also
caused by T. rubrum) is extremely common in patients
with toenail onychomycosis.
Clinical Presentations:
Patterns of Nail Plate Invasion
Table 1. Clinical Signs of Onychomycosis
(Toenails or Fingernails)
• Onycholysis
• Debris under the nail plate
• Subungual hyperkeratosis
• Discoloration (usually nontransparent white or yellow
discoloration; less frequently, brown pigmentation)
• Destruction of all or part of the nail plate
Several patterns of nail plate invasion have been described.4
The most common of these is invasion of the nail plate from
the hyponychium (distal-lateral-subungual onychomycosis)
(Figure 2). In the presentation known as proximal subungual
onychomycosis (Figure 3), the organisms invade the proximal
nail bed via the cuticle. This is an unusual presentation in
immunocompetent individuals; the presence of proximal
subungual onychomycosis should raise the index of suspicion for an underlying cause of immunosuppression.
Superficial white onychomycosis is characterized by direct
invasion of the nail plate surface, causing leuconychia and
crumbling of the plate (Figure 4).
Chronic mucocutaneous candidiasis is a presentation that is
caused by Candida albicans, which affects the entire nail
unit. Normally, Candida cannot invade the nail plate in
immunocompetent patients. Candida may be a secondary
invader in onycholysis and chronic paronychia (Figure 5).
Diagnosis, Clinical Implications, and Complications of Onychomycosis
S7
Differential Diagnosis
Onychomycosis can mimic many other clinical conditions
that affect the nail, such as trauma, other infections, and
inflammatory processes including psoriasis and, occasionally, neoplastic conditions. When a solitary nail is involved,
the possibility of a subungual tumor such as onychomatricoma or exostosis may be considered. The differential
diagnosis of onychomycosis in adults is listed in Table 2.5,6
Exogenous substances can cause nail dyschromia that
can mimic onychomycosis. Nail polish can stain the nail
yellow, and other products, such as self-tanning cream,
can stain the nail plate brown. Exposure to a number of
substances can cause changes in nails that resemble infectious processes. In addition, physiologic changes occur
with aging that resemble fungal dyschromia and dystrophy
(Figure 6).
Finally, certain systemic medications are known to
induce nail changes. For example, antineoplastic drugs
may cause onycholysis, and sun exposure during tetracycline therapy may cause photo-onycholysis. Retinoids may
cause nail brittleness.
In children, the differential diagnosis includes several
uncommon clinical conditions (Table 3).7 However, a history
of onychomycosis and/or tinea pedis in the family or other
household members suggests a dermatophyte infection.
Figure 7. Sampling scrapings for KOH preparation or culture. A scraping of the
surface of the nail (A) usually does not provide sufficient material for study. The
most viable hyphae are under the nail plate; clipping followed by paring (B) yields
the most useful sample. Photo courtesy of Phoebe Rich, MD.
Laboratory Confirmation
of Clinical Diagnosis
onychomycosis and aging. Even after the infection has been successfully treated,
age-related dyschromia can be expected to persist. Photo courtesy of Phoebe Rich, MD.
The diagnosis of onychomycosis should be confirmed prior
to institution of treatment. A diagnosis of onychomycosis
often has been made based on clinical impressions alone,
particularly in cases of mild infections limited to partial
involvement of one or only a few nails and especially when
topical therapy—rather than systemic therapy—is prescribed. However, this is no longer considered the ideal
practice, given what is now known about the potential
clinical sequelae of onychomycosis, the importance of
selecting the most appropriate treatment, and the possibility
of misdiagnosis of nail disease from other causes (such as
immune dysfunction8 or psoriasis9).
A definitive diagnosis of the presence of a fungal infection
may be readily made in the office by use of a potassium
hydroxide (KOH) preparation. In patients with the distal
subungual pattern, the nail should be debrided as far back
as possible and a specimen of subungual debris obtained
from the area as close to the cuticle as possible (Figure 7).
Alternatively, scale from the involved portion of the nail plate
can be used. Scrapings from the surface of the involved nail
plate is preferred in patients with suspected superficial white
onychomycosis. In those with a proximal subungual presentation, it is necessary to sample the deeper nail plate and bed.
To dissolve the subungual debris and make it easier to
visualize the fungus, dimethyl sulfoxide can be added to
the 10% to 15% KOH solution on the glass slide. Fungal
stains (chlorazol black E or Parker blue-black ink) may be
used to enhance microscopic visualization.
Table 2. Differential Diagnosis of Onychomycosis in Adults5,6
Table 3. Differential Diagnosis of Onychomycosis in Children7
• Psoriasis
• Nail psoriasis
• Nail trauma
• Congenital malalignment of large toenail
• Contact irritants
• Subungual exostosis
• Lichen planus
• Subungual warts
• Neoplasms
• Subungual hematoma
• Bacterial infection
(Pseudomonas aeruginosa, Proteus mirabilis)
• Parakeratosis pustolosa
Figure 6. Dyschromia. Yellowing and discoloration may result from both
• Paronychia secondary to finger sucking
S8
The main advantage of office-based testing is rapid confirmation that a fungus is present. The main disadvantage
is that the fungus itself is not specifically identified nor is
the presence of nondermatophyte organisms. Another disadvantage of direct microscopy is that an inexperienced
observer may misinterpret the results.
KOH of subungual debris and periodic-acid Schiff (PAS)
staining of nail plate samples provide confirmation of
organisms but do not identify or ascertain the viability of
organisms present. Culture is slower and less sensitive but
currently is the standard method for identifying the causative organism. Polymerase chain reaction may become a
useful method.
PAS showing septate hyphae is diagnostic, but PAS showing
only yeast forms is not conclusive evidence of infection.
Laboratory results of PAS staining of nail clippings are usually
available within a few days. Nail clippings also may be
obtained for histologic analysis.
The gold standard of diagnosis for onychomycosis is a
fungal culture. Culturing is the only method that is widely
available at this time that provides definitive identification
of a specific organism, which is particularly important when
yeasts or other nondermatophyte organisms are a suspected
cause of onychomycosis. Such identification allows choice
of a systemic agent that is most likely to be effective.
When other tests fail to provide definitive results, a nail
biopsy should be considered.10
Conclusion
In most patients, it is likely that a clinical suspicion of dermatophytic onychomycosis can be derived based on the
patient’s personal and family history and on careful inspection of both fingernails and toenails. However, the diagnosis
should be confirmed—using, at minimum, an office-based
KOH preparation—prior to initiating therapy. In addition,
under the circumstances described in this article, a culture
should be performed to obtain a definitive diagnosis and
identification of the causative organism.
References
1. Ghannoum MD, Hajjeh RA, Scher R, et al. A large-scale North American study
of fungal isolates from nails: The frequency of onychomycosis, fungal distribution,
and antifungal susceptibility patterns. J Am Acad Dermatol. 2000;43:641-648.
2. Scher RK, Elewski B, Rich P, Pariser D. The epidemiology, etiology, and pathophysiology of onychomycosis. Semin Cutan Med Surg 2013;33:7-9.
3. Foster KW, Ghannoum MA, Elewski BE. Epidemiologic surveillance of cutaneous fungal infection in the United States from 1999 to 2002. J Am Acad
Dermatol. 2004;50:748-752.
4. Baran R, Hay RJ, Tosti A, Haneke E. A new classification of onychomycosis.
Br J Dermatol. 1998;139:567-571.
5. Cockerell C, Odom R. The differential diagnosis of nail disease. AIDS Patient
Care. 1995;9(suppl 1):S5-S10.
6. Daniel CR III. The diagnosis of nail fungal infection. Arch Dermatol. 1991;
127:1566-1567.
7. Tosti A, Piraccini BM, Iorizzo M. Management of onychomycosis in children.
Dermatol Clin. 2003;21:507-509.
8. Sherber N, Wigley FM, Scher RK. Autoimmune disorders: Nail signs and
therapeutic approaches. Dermatol Ther. 2007;20:17-30.
9. Rich P, Griffiths CEM, Reich K, et al. Baseline nail disease in patients with
moderate to severe psoriasis and response to treatment with infliximab during
1 year. J Am Acad Dermatol. 2008;58:224-231.
10. Rich P. Nail biopsy: Indications and methods. Dermatol Surg. 2001;27:229-234.
Current and Emerging Options in
the Treatment of Onychomycosis
Boni Elewski, MD,* David Pariser, MD,† Phoebe Rich, MD,‡ Richard K. Scher, MD§
ABSTRACT Currently approved options for the treatment of onychomycosis include systemic
therapy (the antifungal agents fluconazole, itraconazole, and terbinafine), topical agents
(ciclopirox, which has been available since 1996, efinaconazole, currently pending
approval), and laser systems. Phase III studies on another topical, tavaborole, have been
completed and this medication also shows promise. Mechanical modalities are sometimes
used but are seldom necessary. Recurrence of infection is common; the risk for recurrence
may be reduced by adherence to preventive measures, especially avoiding (if possible) or
promptly treating tinea pedis infections.
Semin Cutan Med Surg 32(suppl):S9-S12 © 2013 published by Frontline Medical Communications
KEYWORDS ciclopirox; efinaconazole; fluconazole; fungal infections; itraconazole; nail infections;
onychomycosis; tavaborole; terbinafines
T
he goal of onychomycosis treatment is to eradicate the
causative organism. Elimination of the fungus generally
restores the appearance of the nail in most cases. However,
patients should not expect to see normal-appearing nails
until after the fungi are eliminated and until the damaged
nail has grown out—a process that, for fingernails, may
take 6 months or more from the time effective treatment is
*Vice-Chair for Clinical Affairs, Professor of Dermatology
University of Alabama School of Medicine, Birmingham, AL
†Professor of Dermatology, Eastern Virginia Medical School
Department of Dermatology, Pariser Dermatology, Norfolk, VA
‡Clinical Adjunct Professor of Dermatology, Oregon Health Science
University, Portland, OR
§Clinical Professor of Dermatology, Weill Cornell Medical College
New York, NY
Publication of this CME article was jointly sponsored by the University
of Louisville School of Medicine Continuing Medical Education and
Global Academy for Medical Education, LLC and is supported by an
educational grant from Medicis, a division of Valeant Pharmaceuticals.
The faculty have received an honorarium from Global Academy for
Medical Education for their participation in this activity. They
acknowledge the editorial assistance of Joanne Still, medical writer,
and Global Academy for Medical Education in the development of this
continuing medical education journal article. Joanne Still has no
relevant financial relationships with any commercial interests.
Boni Elewski, MD, has been an investigator for Anacor and Valeant.
David Pariser, MD, has been a consultant and/or investigator and/or
advisory board member with Abbott Laboratories, Amgen, Astellas
Pharma US, Inc, Basilea, Celgene Corporation, Dow Pharmaceutical
Sciences, Inc., DUSA Pharmaceuticals, Inc., Eli Lily and Company,
Galderma Laboratories, L.P., Genentech, Inc., Graceway Pharmaceuticals,
LLC, Intendis, Inc., Janssen-Ortho Inc, Johnson & Johnson Consumer
Products Company, LEO Pharma, US, Medicis Pharmaceutical
Corporation, MelaSciences, Novartis Pharmaceutical Corporation, Novo
Nordisk A/S, Ortho Dermatologics, Peplin Inc., Pfizer, Photocure ASA,
Proctor & Gamble Company, Stiefel a GSK company, and Valeant
Pharmaceuticals International.
Phoebe Rich, MD, has been a principal investigator and/or consultant
for Valeant, Dow Pharmaceuticals, Topica, and Tolmar.
Richard K. Scher, MD, is an advisor/consultant to Valeant.
Address reprint requests to: Boni Elewski, MD, UAB Department of
Dermatology, 1720 2nd Avenue South, EFH – Suite 414, Birmingham, AL
35294-0009, Telephone: (205) 975-4917, E-mail: [email protected]
1058/5629/13/$-see front matter © Frontline Medical Communications
http://dx.doi.org/10.12788/j.sder.0016
initiated and, for toenails, 12 to 18 months. Toenails grow
at the rate of about 1 to 2 mm per month and fingernails
grow faster, at the rate of 2 to 3 mm per month; however,
nail growth rate peaks during the teenage years and
decreases with advancing age.1
Some onychomycosis infections, especially those involving the nail matrix, may produce permanent scarring of the
matrix, and, thus, the nail may never appear normal even
after the infection is completely eradicated (Figure 1).
The definition of “complete cure,” as defined by the US
Food and Drug Administration (FDA) for the evaluation of
clinical trial results, is negative results on potassium
hydroxide (KOH) preparation and on fungal culture, as well
as a completely normal appearance of the nail. In clinical
practice—and for practical purposes—most cures will be
defined by the absence of fungus on KOH preparation and
possibly, but not always, by a completely normal nail
(Figure 2). Realistically, patients who have had long-standing infections or chronic onychomycosis are likely to have
sustained damage to the nail matrix or subungual area so
that, despite the clearance of infectious organisms, new nail
growth may be permanently discolored and/or dystrophic,
and some onycholysis (lifting of the nail plate) may persist.
Furthermore, nails may be thickened, discolored, and dystrophic for reasons other than mycotic infection—as is
Figure 1. Persistence of dystrophia after mycologic cure. In some cases, permanent
scarring of the nail matrix may occur, so a normal appearance may not be restored
even after the infection is eradicated. Photo courtesy of Phoebe Rich, MD.
S9
S10
Table 1. Summary of Treatment Options for Onychomycosis
A. Topical Therapy
Fingernails and Toenails
Ciclopirox 8%
Apply daily, up to 48 weeks10
Efinaconazole
Phase III clinical trials studied daily application for 48 weeks11
Tavaborole
Phase III clinical trial (data available on first of two recently completed) studied daily application for 52 weeks12
B. Systemic Therapy
Fingernails
Fluconazole3*
3 to 8 mg/kg pulsed-dose weekly for 6 weeks OR 200 mg/week for 8 to 16 weeks
Itraconazole4
400 mg/day for 1 week/month, repeated for 2 or 3 months†
Terbinafine7
250 mg/day for 6 weeks
Toenails
Fluconazole3
200 mg/week for 12 to 24 weeks
Itraconazole5
400 mg/day for 1 week/month, repeated for 3 or 4 months‡
Terbinafine7
250 mg/day for 12 weeks
*Although it is commonly used for onychomycosis, this is not an FDA-approved indication for fluconazole.
†Note that the dosage recommended in the prescribing information for fingernails is 400 mg/day (two 200-mg capsules twice daily) for 1 week, followed by
a 3-week period of no treatment, then a second treatment pulse of 400 mg/day/1week.
‡Note that the dosage recommended in the prescribing information for toenails, with or without fingernail involvement, is 200 mg (2 capsules) once daily for
12 consecutive weeks.
common, for example, in elderly patients who have agerelated changes in the nails or onychogryphosis, or even in
patients with inflammatory disorders such as psoriasis.
Systemic Therapy
Systemic antifungal therapy options currently include
itraconazole, terbinafine, and fluconazole. A summary of
systemic antifungal agents and cure rates can be found in
Tables 1 and 2. A meta-analysis of studies involving these
medications demonstrated low risk for side effects in
immunocompetent patients.2
Fluconazole is not approved by the FDA for this indication,
although it is approved for fingernail and toenail onychomycosis in other countries. It was originally tested in dosages of
150 mg/week, 300 mg/week, and 450 mg/week for up to 9
months or until clearance of the nail.3 In an FDA study, clinical cures were seen in 48% of patients who received 450 mg/
week, 46% of those who received 300 mg/week, and 37% of
those who received 150 mg/week.3 However, probably a
dosage of 200 mg or 400 mg once weekly is effective, and
once-weekly dosing is convenient for patients on multiple
medications and the elderly. Fluconazole can be taken with
or without food; the drug must be avoided in pregnant
women. Drug interactions are via CYP2C9.
Itraconazole can be used to treat fingernail or toenail
onychomycosis. It may be given according to either of two
dosing schedules, for a duration of 2 to 3 months for fingernail infections and 3 to 4 months for toenail infections.4
Regimen 1 is 400 mg/day for 7 days for 1 week out of each
month for 4 months. Regimen 2 is 200 mg/day continuously
for 3 months. Regimen 1 (pulsed dosage) is not approved
for treating toenail onychomycosis. The cure rate for
Regimen 2 (continuous dosage) per the package insert is
14%.4 Evans and colleagues5 reported higher cure rates for
pulsed (intermittent) dosing in the Lamisil vs Itraconazole
in Onychomycosis (LION) study: 25% complete cure in
three cycles; 28% complete cure in four cycles.
Itraconazole is a potent inhibitor of CYP3A4 and may result
in serious cardiovascular events if used simultaneously with
cisapride, pimozine, quinidine, or levomethadyl. It must be
used with caution when treating onychomycosis in patients
with congestive heart failure or other ventricular dysfunction.
Ahmad and colleagues6 reported that itraconazole has a negative inotropic effect on the heart in healthy individuals.
Terbinafine is used at a dosage of 250 mg/day for 6 weeks
for fingernails and for 12 weeks for toenails.7 Drake and
colleagues8 reported a complete cure rate of 38% with
250 mg/day for 3 months and no significant difference in
response between 12-week and 24-week treatment courses.
In the LION study, Evans and colleagues5 found that terbinafine produced a 49% complete cure with a 12-week
course and a 54% complete cure with a 16-week course.
Pulsed-dose therapy with terbinafine is not FDA approved.
Tosti and colleagues9 noted that most studies show that continuous therapy of daily 250-mg dosing was more efficacious than
500 mg daily for 1 week followed by 3 weeks of no treatment.
Topical Therapy
Figure 2. Before and after successful systemic therapy. This patient presented with
distal subungual oncyhomycosis. Note the distortion of the nail before treatment
(left) and the resolution of onycholysis and discoloration after 4 months of systemic
therapy (right). Photo courtesy of Phoebe Rich, MD.
Assuming reasonable efficacy could be assured, topical
therapy would be the preferred methodology for onychomycosis to avoid systemic side effects and the need for laboratory
monitoring. In addition, if adverse reactions occur from
topical agents, the effect is site-specific and, as such,
Current and Emerging Options in the Treatment of Onychomycosis
S11
Table 2. Complete Cure Rates in Onychomycosis Reported in Clinical Studies*
A. Topical Therapy
Medication and Regimen (Once-daily Application)
Complete Cure Rates
Ciclopirox 8%10
5.5% to 8.5%
Efinaconazole11
15% and 18%†
Tavaborole12
6.5%‡
B. Systemic Therapy
Medication (Regimen)
Complete Cure Rates
Fluconazole3
150 mg/week
300 mg/week
450 mg/week
37%
46%
48%
Itraconazole
14%
200 mg/day for 12 weeks4
400 mg/day for 1 week/month5
Repeated for 3 pulses
Repeated for 4 pulses
25%
28%
Terbinafine
38%
250 mg/day for 12 weeks8
250 mg/day for 1 week/month5
Repeated for 3 pulses
Repeated for 4 pulses
38%
49%
54%
*The dosages shown above are not necessarily those approved by the US Food and Drug Administration.
† Data from two phase III, double-blind studies.
‡Data from the first of two phase III clinical trials recently completed.
generally is more acceptable to patients. However, no topical
treatment has been approved as monotherapy to date. A
summary of topical antifungal agents and cure rates can be
found in Tables 1 and 2.
The development of topical therapy for onychomycosis
presents unique challenges. First, to be effective, the drug
must penetrate through the nail plate and reach the nail bed
in sufficient quantities. This requires overcoming the
unique properties of the nail plate—its thickness and relatively compact structure. The factors involved probably
include the proper molecular weight, lipophilicity, and
keratin-binding properties.
Ciclopirox 8% lacquer, which was approved by the FDA
in 1999, is associated with a complete cure rate ranging
from 5.5% to 8.5% but requires frequent nail debridement.
In clinical studies, fewer than 12% of patients were able to
achieve a clear or almost-clear nail.10
New and Investigational Topical Agents
A new topical agent, efinaconazole, currently pending approval
by the FDA, will be the first topical triazole to become available for dermatologic use and the first new antifungal for
onychomycosis to be introduced in more than a decade.
Unlike ciclopirox, no debridement of nails is required.
Efinaconazole is a solution, not a lacquer, so, unlike
ciclopirox, efinaconazole does not need to be removed each
week. The solution is applied on, under, and around the
nail. In the pivotal clinical trials, efinaconazole yielded a
mycologic cure in the range of 50%. Complete cure was seen
in 15% of patients in one study and 18% of patients in the
second phase III study. Cure classified as “almost complete”
exceeded 20%.11
Currently in the research pipeline is topical tavaborole
5% solution. In the first of two phase III clinical trials
recently completed, the primary end point of complete cure
(both mycologic cure and a completely clear nail) was seen
in 6.5% of patients versus 0.5% of patients treated with
vehicle alone (P=0.001). In addition, a negative fungal
culture was reported after 52 weeks of treatment in 87% of
patients on tavaborole versus 47.9% of those in the vehicle
group (P<0.001); at the same time point, a negative nail
culture and “completely clear” or “almost clear” nail was
seen in 24.6% of patients in the tavaborole group versus
5.7% in the vehicle group (P<0.001).12
Over-the-Counter (OTC) Treatments
A mention of nonspecific topical OTC and “folk” remedies
is appropriate here. Many such remedies have been used—
usually self-prescribed by patients—as monotherapy or in
the belief that these agents will enhance the efficacy of
prescription medications. Currently popular are tea tree oil
and a camphor-containing ointment marketed as a chest
rub. Many other substances have been used, including foot
soaks with hydrogen peroxide or household chlorine bleach
and applications of salicylic acid, as well as OTC solutions,
creams, and ointments.
Evidence-based studies have not been done demonstrating that these agents are helpful, but there is some theoretical
scientific basis for anecdotal claims of efficacy by patients—
and by some clinicians—when these remedies have been
S12
used diligently. Although they cannot be recommended on
the basis of evidence of efficacy, most of these methods are
neither harmful nor costly. Patients who choose to forgo prescription therapy for whatever reason should not be discouraged
from trying these remedies for a time and told to reconsider
definitive treatment if the infection does not clear or worsens.
Mechanical Modalities
Nail avulsion and matrixectomy are seldom needed. These
techniques may be appropriate if only one nail is affected
and the infection does not respond to other treatments, as
well as in cases of infections with nondermatophyte mold
organisms. However, most patients have involvement of
more than one nail. Occasionally, patients develop thickened dystrophic nails that are painful or interfere with
proper ambulation. Such circumstances also may constitute
an indication for surgical intervention.
Lasers, photodynamic therapy (PDT), and other methods
have been used with varying degrees of success in treating
onychomycosis. The laser devices approved by the U.S. FDA
to date are the short-pulse neodymium-doped yttrium aluminum garnet (Nd:Yag) type, although other types currently
are being studied; these include carbon dioxide, near infrared diode, and femtosecond infrared laser systems.
The exact mechanism of action of laser systems in onychomycosis has not been established. One early proposed
mechanism was the direct action of heat on the infecting
organisms,13 but recent in vitro studies show that lasergenerated heat to a level required to kill Trichophyton rubrum
is much higher than what would be tolerable; experiments
with direct lasering of fungi have not affected the growth
of fungal organisms. Others have suggested that the use of
lasers may enhance the efficacy of other modalities.14,15
More likely mechanisms of action are the triggering of an
immunologic effect or laser-induced denaturization of
enzymes essential to fungal activity.
As the results of ongoing research provide additional
insights regarding treatment regimens and patient selection
along with longer-term evidence of efficacy, laser systems may
become more widely used for treating onychomycosis.
The mechanism of action of PDT in dermatophytic onychomycosis has been established and involves eradication
of the organism.16-18 No PDT system has been approved by
the FDA for the treatment of onychomycosis, and it is not
a practical therapeutic option. However, PDT may be useful
in chronic cases that are refractory to other modalities,
particularly when the causative organism is uncommon,
such as a nondermatophyte mold.19
Other devices and modalities continue to be developed and
investigated, including the use of iontophoresis to enhance
penetration of a topical medication through the nail plate.20
Preventing Recurrence
Reinfection with dermatophytic onychomycosis is
common.21,22 It is difficult to know whether subsequent
infection is a new infection or whether the original infection
was not cleared completely and recurred after weeks,
months, or years of dormancy. In either case, patients must
understand that it is unlikely that one course of treatment
will be all that is required over the long term.
However, it is important to emphasize that the risk for
reinfection can be reduced by avoiding practices that expose
the nails to infectious organisms and that create a milieu
that encourages fungal colonization. (See the patient
handout in the article in this supplement by Pariser et al.23)
Conclusion
Onychomycosis is a common problem that increases in
prevalence with increasing age. Simple techniques are readily
available for making an accurate diagnosis in all patients. The
only prescription topical agent available has been ciclopirox
8% lacquer. A new topical agent, efinaconazole, currently
pending approval by the FDA, provides better efficacy.
Another topical agent, tavaborole, has shown good results in
phase III studies to date. Systemic agents are highly effective
for many patients but are contraindicated or otherwise inadvisable for some because of the potential for drug interactions
or the presence of certain comorbidities.
References
1. Abdullah L, Abbas O. Common nail changes and disorders in older people:
Diagnosis and management. Can Fam Physician. 2011;57:173-181.
2. Chang CH, Young-Xu Y, Kurth T, Orav JE, Chan AK. The safety of oral antifungal treatments for superficial dermatophytosis and onychomycosis:
A meta-analysis. Am J Med. 2007;120:791-798.
3. Scher RK, Breneman D, Rich P, et al. Once-weekly fluconazole (150, 300, or
450 mg) in the treatment of distal subungual onychomycosis of the toenail.
J Am Acad Dermatol. 1998;38 (6, pt 2):S77-S86.
4. Sporanox (itraconazole) [package insert]. Raritan, NJ: PriCara, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc; 2011.
5. Evans EGV, Sigurgeirsson B for the LION Study Group. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole
in treatment of toenail onychomycosis. BMJ. 1999;318:1031-1035.
6. Ahmad SR, Singer SJ, Leissa BG. Congestive heart failure associated with
itraconazole. Lancet. 2001;357:1766-1767.
7. Lamisil (terbinafine) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals;
2012.
8. Drake LA, Shear NH, Arlette JP, et al. Oral terbinafine in the treatment of
toenail onychomycosis: North American multicenter trial. J Am Acad Dermatol.
1997;37(5, pt1):740-745.
9. Tosti A, Piraccini BM, Stinchi C, Colombo MD. Relapses of onychomycosis
after successful treatment with systemic antifungals: A three-year follow-up.
Dermatology. 1998;197:162-166.
10. Penlac (ciclopirox 8%) [package insert]. Bridgewater, NJ: Dermik Laboratories; 2006.
11. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment
of toenail onychomycosis: Two phase III multicenter, randomized, double-blind
studies. J Am Acad Dermatol. 2013;68:600-608.
12.Tavaborole (AN2690). Available at: http://www.anacor.com/an2690.php.
Accessed March 24, 2013.
13. Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser
irradiation on Trichophyton rubrum growth. Lasers Med Sci. 2008;23:349-353.
14. Murdan S. Enhancing the nail permeability of topically applied drugs. Expert
Opin Drug Deliv. 2008;5:1267-1282.
15. Borovoy M, Tracy M. Noninvasive CO2 laser fenestration improves treatment
of onychomycosis. Clin Laser Mon. 1992;10:123-124.
16. Piraccini BM, Rech G, Tosti A. Photodynamic therapy of onychomycosis caused
by Trichophyton rubrum. J Am Acad Dermatol. 2008;59(5 suppl):S75-S76.
17. Watanabe D, Kawamura C, Masuda Y, Akita Y, Tamada Y, Matsumoto Y.
Successful treatment of toenail onychomycosis with photodynamic therapy.
Arch Dermatol. 2008;144:19-21.
18. Donnelly RF, McCarron PA, Lightowler JM, Woolfson AD. Bioadhesive patchbased delivery of 5-aminolevulinic acid to the nail for photodynamic therapy
of onychomycosis. J Control Release. 2005;103:381-392.
19. Gilaberte Y, Aspiroz C, Martes MP, Alcalde V, Espinel-Ingroff A, Rezusta A.
Treatment of refractory fingernail onychomycosis caused by nondermatophyte
molds with methylaminolevulinate photodynamic therapy. J Am Acad Dermatol.
2011;65:669-671.
20. Gupta A, Brintnell W. Onychomycosis therapy: Past, present, and future. J Am
Acad Dermatol. 2012;66(4 suppl 1):AB120.
21. Piraccini BM, Sisti A, Tosti A. Long-term follow-up of toenail onychomycosis
caused by dermatophytes after successful treatment with systemic antifungal
agents. J Am Acad Dermatol. 2010;62:411-414.
22. Gupta A, Cooper E. Examination of cure and relapse of dermatophyte toenail
onychomycosis during long-term follow-up after oral therapy. J Am Acad
Dermatol. 2012;66(4 suppl 1):AB119.
23. Pariser D, Elewski B, Scher RK, Rich P. Promoting and maintaining or restoring
healthy nails: Practical recommendations for clinicians and patients. Semin
Cutan Med Surg. 2013;33:19-20.
Promoting and Maintaining or Restoring
Healthy Nails: Practical Recommendations
for Clinicians and Patients
David Pariser, MD,* Richard K. Scher, MD,† Boni Elewski, MD,‡ Phoebe Rich, MD§
ABSTRACT The American Academy of Dermatology guidelines for managing patients with
onychomycosis, published almost 2 decades ago, provide sound, basic recommendations
for clinicians. This article provides a quick reference for clinicians and includes a handout for
patients to support the health care provider’s educational efforts.
Semin Cutan Med Surg 32(suppl):S13-S14 © 2013 published by Frontline Medical Communications
KEYWORDS fungal infections; nail infections; onychomycosis
G
uidelines for managing patients with onychomycosis
were last published in 1996.1 In the absence of the
availability of new medications since that time or of new
data on existing agents that suggested the need for a change
in the guidelines, an update has not been necessary. The
*Professor of Dermatology, Eastern Virginia Medical School
Department of Dermatology, Pariser Dermatology, Norfolk, VA
† Clinical Professor of Dermatology, Weill Cornell Medical College
New York, NY
‡Vice-Chair for Clinical Affairs, Professor of Dermatology
University of Alabama School of Medicine, Birmingham, AL
§Clinical Adjunct Professor of Dermatology, Oregon Health Science
University, Portland, OR
Publication of this CME article was jointly sponsored by the University of
Louisville School of Medicine Continuing Medical Education and Global
Academy for Medical Education, LLC and is supported by an educational
grant from Medicis, a division of Valeant Pharmaceuticals.
The faculty have received an honorarium from Global Academy for
Medical Education for their participation in this activity. They
acknowledge the editorial assistance of Joanne Still, medical writer,
and Global Academy for Medical Education in the development of this
continuing medical education journal article. Joanne Still has no
relevant financial relationships with any commercial interests.
Boni Elewski, MD, has been an investigator for Anacor and Valeant.
David Pariser, MD, has been a consultant and/or investigator and/or
advisory board member with Abbott Laboratories, Amgen, Astellas
Pharma US, Inc, Basilea, Celgene Corporation, Dow Pharmaceutical
Sciences, Inc., DUSA Pharmaceuticals, Inc., Eli Lily and Company,
Galderma Laboratories, L.P., Genentech, Inc., Graceway Pharmaceuticals,
LLC, Intendis, Inc., Janssen-Ortho Inc, Johnson & Johnson Consumer
Products Company, LEO Pharma, US, Medicis Pharmaceutical
Corporation, MelaSciences, Novartis Pharmaceutical Corporation, Novo
Nordisk A/S, Ortho Dermatologics, Peplin Inc., Pfizer, Photocure ASA,
Proctor & Gamble Company, Stiefel a GSK company, and Valeant
Pharmaceuticals International.
Phoebe Rich, MD, has been a principal investigator and/or consultant
for Valeant, Dow Pharmaceuticals, Topica, and Tolmar.
Richard K. Scher, MD, is an advisor/consultant to Valeant.
Address reprint requests to: David Pariser, MD, Professor of Dermatology,
Eastern Virginia Medical School, Department of Dermatology, Pariser
Dermatology, 601 Medical Tower, Norfolk, VA 23507, E-mail: dpariser@
pariserderm.com
1058/5629/13/$-see front matter © Frontline Medical Communications
http://dx.doi.org/10.12788/j.sder.0017
management of onychomycosis is straightforward and can
be summarized as follows:
• Inspect clinically and take a thorough personal and
family history.
• Consider the differential diagnosis. Onychomycosis accounts
for at least half of all cases of nail infection, particularly
toenail infections. In patients who are not immunocompromised, psoriasis and lichen planus should be the first
two considerations in the differential diagnosis.
• Confirm the diagnosis with a laboratory study: potassium
hydroxide, periodic-acid Schiff stain, or fungal culture.
(In the future, analysis by polymerase chain reaction may
become widely available.)
• Consider the treatment options. If onychomycosis is confirmed, consider the available treatments. Factors to
include are the site of disease (toenails or fingernails), the
extent of disease, and the patient’s age, immune status,
and concomitant conditions that may limit systemic
choices or are likely to affect treatment efficacy, including
severely thickened nails, compromised peripheral circulation, and the presence of diabetes mellitus. In addition,
consider the patient’s health insurance coverage in the
equation; some carriers will cover topical therapy only
after a systemic treatment has been tried first.
• Discuss your recommendations with the patient. If the infection is limited to 50% or less of the nail plate of only one
or a few toes, topical therapy is an option. Be clear about
the cure rates associated with the proposed therapies. If
systemic therapy is considered, discuss the potential side
effects of the available systemic agents and inform the
patient about any baseline and follow-up blood testing
that will be required.
S13
S14
• Discuss realistic expectations for immediate and long-term
treatment results. Patients must understand that one course
of treatment may not produce the optimum result and
that recurrence of onychomycosis is very common. It is
also important to advise patients about the point in time
that visible results can be expected (ie, the rate of nail
growth), and that clearance of an infection will be evident
only as nails grow.
Reference
1.Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for superficial
mycotic infections of the skin: Onychomycosis. J Am Acad Dermatol. 1996;
34:116-121.
• Emphasize the role of preventive measures to avoid reinfection.
For example, one of the most common ways that patients
acquire infection with organisms such as T. rubrum is
walking barefoot in pools, spas, gymnasiums, and locker
rooms-areas where moisture is present and where fungi
can thrive. Another common source of infection is the
nail salon.
Individuals should bring their own nail clippers, files,
and emery boards to the salon, and ensure that the technician washes the nail-soaking dish or pedicure tub with
bleach between clients. Prompt treatment at the first signs
of athlete’s foot infection can also reduce the recurrence
of onychomycosis.
Onychomycosis Patient Handout
An educational handout accompanies this article on the
following two pages. The handout may be freely copied by
clinicians and distributed to patients. Other uses, such as
inclusion in published materials or presentations, require
proper attribution for the authors and permission from the
publisher. A Spanish-language version of this handout is
available online at at www.globalacademycme.com/sdef in
the CME Library under the title, “Onychomycosis Information
for Patients.”
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Onychomycosis Information for Patients
What is onychomycosis?
Nail fungus infection, called onychomycosis (ON-ick-co-my-CO-sis), usually affects the toenails but
also may occur on the fingernails. Most cases of onychomycosis are caused by the same fungus
that is responsible for athlete’s foot.
Surface View
Nail infections most commonly affect the toenails.
The fungus organisms usually invade the nail bed
from the outside (distal) edge of the nail. Sometimes
the nail plate itself is the original site of infection.
Onychocomeal/
Onychodermal Band
Hyponychium
Nail Plate
Lateral
Nail Fold
Lunuta
Eponychium/
Cuticle
Side View
Nail Plate
Proximal Nail Fold
Eponychium
True Cuticle
Lunuta
Distal Edge
Nail Bed
Proximal Nail Fold
Who gets onychomycosis?
About 10% to 12% of people, overall, have onychomycosis. However, this is an average for the
population. Actually, onychomycosis is more common in some groups of people than in others.
For example, onychomycosis is seldom seen in children. When children get onychomycosis, it
is usually because a teenager or adult in the household has athlete’s foot and onychomycosis.
Also, onychomycosis is most common in older people; a large percentage of individuals more
than 70 years of age have the infection.
People who tend to get athlete’s foot infections also have a higher risk for onychomycosis of the toenails.
Injuries to the toes—even minor injuries—also can increase the chances of getting onychomycosis.
Onychomycosis is also more common in people with certain medical conditions: diabetes, psoriasis or
other autoimmune disease, HIV/AIDS infection, and poor circulation in the feet and hands.
What are the signs and symptoms of onychomycosis?
The most common signs and symptoms of onychomycosis are:
• Brittleness of the nail(s)
• Change in nail shape
• Crumbling of the outside edges of the nails
• Debris trapped under the nail
• Loosening or lifting up of the nails at the outside edges
• Loss of luster and shine
• Thickening of the nail
• White or yellow streaks on the nail
These suggest the presence of an infection, but the proper treatment is chosen based on a firm
diagnosis by a medical professional. The diagnosis can be made in the health care provider’s office
by taking scrapings of the nail and examining the sample under a microscope to determine whether
a fungus is present. The results of this test are immediate.
Sometimes the health care provider will decide that more involved testing is necessary, and he or
she will send the sample for a culture. Laboratory identification of the infecting organism by culture
can take several weeks. Your clinician will determine the best method in your case.
How is onychomycosis treated?
Prescription medications, either oral or topical (applied to the nail) offer the best chance to clear onychomycosis. Also available are non-drug therapies such as laser treatment. Your health care provider
will discuss these with you and will make a treatment recommendation that is tailored to your needs.
Nonprescription over-the-counter products and “folk” remedies (such as tea tree oil and hydrogen
peroxide) generally do not work. However, many people—including many health professionals—
think they might help support the activity of the prescription medications and may help prevent the
recurrence of onychomycosis later on.
This two-sided handout developed by David Pariser, MD, Boni Elewski, MD, Phoebe Rich, MD, and Richard K. Scher, MD may be freely duplicated and distributed, without charge,
to patients and parents. Other uses, such as inclusion in published materials or presentations, require proper attribution for the authors and permission from the publisher.
Supported by an educational grant from Medicis, a division of Valeant Pharmaceuticals. © 2013 Global Academy for Medical Education, LLC. All Rights Reserved.
Is treatment always effective?
There is no “quick fix,” and not every medication will work for everyone. About 50% of patients
experience a clearance of the fungus with the first treatment. If your infection does not clear
completely, your health care provider may recommend a different medication. It is important to
follow these recommendations.
Remember, though, that nails grow slowly, and improvement can be seen only when the “new” nail
grows in. For this reason, it may take several months to see clearing of onychomycosis. Fingernails
grow faster than toenails, and nails in older individuals tend to grow more slowly than do those in
younger people.
It is also important to remember that even if the fungus is cleared, it is common for it to return.
This does not mean that medical treatment is useless; it means that onychomycosis tends to be
stubborn and requires attention over the long term.
How can new infections be prevented?
The following tips can help prevent new infections:
At home:
•Throw away old shoes, particularly sneakers, running shoes, or other types of athletic shoes
that you have used for exercise or sports.
•Use antifungal spray or powder in your shoes every day.
•Apply antifungal creams to your feet periodically to slow the growth of athlete’s foot fungus
(which can then invade the nails).
•Treat all signs and symptoms of athlete’s foot immediately.
•Do not share tools used for manicures and pedicures.
•Do not use the same nail clippers and files on normal nails that are used on nails with a
fungus infection.
•If you see signs of a nail infection, treat it immediately; do not wait until it has progressed.
•Wash and dry your hands thoroughly after contact with any fungal infection.
•Take proper care of your nails. Keep toenails trimmed and clean. Nails should be cut or filed
straight across (not rounded or in a V shape).
•Wear properly fitting shoes with a wide enough toe box so that your toes are not cramped or
hit up against the front of the shoe. (High heels and narrow-toed shoes cause trauma to the
toes and can damage the natural skin seal between the nail itself and the skin underneath,
allowing fungus to invade under the nail.)
•Make sure that household members with athlete’s foot infections receive treatment and take
proper precautions to avoid spreading the fungus to others.
Outside the home:
•Do not walk barefoot in public facilities, such as around pools and in spas, locker rooms, and
gyms. Wear water shoes or rubber sandals.
•Bring your own instruments (especially clippers and emery boards) to the nail salon.
•Make sure your manicurist/pedicurist washes the nail-soaking dish or pedicure tub with bleach
between clients.
Seminars in Cutaneous Medicine and Surgery
Update on Onychomycosis: Effective Strategies for Diagnosis and Treatment
CME Post-Test Answer Sheet
Original Release Date: June 2013 • Most Recent Review Date: June 2013
Expiration Date: June 30, 2015 • Estimated Time to Complete Activity: 2.5 hours
To get instant CME credits online, sign in to the Web site at http://uofl.me/onycho13. Upon successful completion of the
online assessments, you can download and print your certificate of credit. If you have any questions or difficulties, please
contact the University of Louisville School of Medicine Continuing Medical Education office at [email protected].
CME Questions: For each question or incomplete statement, choose the answer or completion that is correct.
Circle the most appropriate response.
1.The type of organism implicated most
commonly in onychomycosis cases in the
United States are:
A.Bacteria
b.Dermatophytes
c.Nondermatophyte molds
d.Yeasts
2. Candida species are the most common
cause of onychomycosis among:
a.Children
b. Elderly patients
c.Immunocompromised patients
d. Individuals with poor peripheral circulation
3.Pediatric patients who present with
onychomycosis almost always have:
a.Compromised immune function
b. Diabetes
c.Family history of tinea pedis
d. Previous toenail injury
4.The most common presentation of
onychomycosis is
a.Chronic mucocutaneous candidiasis
b. Distal-lateral-subungual
c.Proximal subungual
d. Superficial white
5.The current standard method for identifying
the causative organism in onychomycosis is
a.Nail culture
b. Periodic-acid Schiff staining of nail
plate samples
c.Potassium hydroxide preparation of
subungual debris
d. Polymerase chain reaction analysis
6. Which one of the following statements
concerning periodic-acid Schiff (PAS)
staining is true?
a.PAS staining showing septate hyphae
is diagnostic
b. PAS staining showing yeast forms only is not
conclusive evidence of infection
c.PAS staining alone does not confirm that
organisms are present
d. PAS staining ascertains the viability of
organisms present
7.The definition of “complete cure,”
as defined by the US Food and Drug
Administration (FDA) for the evaluation
of clinical trial results, is:
a.Negative results on fungal culture, as well
as a completely normal appearance of
the nail
b. Negative results on potassium hydroxide
(KOH) preparation, as well as a completely
normal appearance of the nail
c.Negative results on potassium hydroxide
(KOH) preparation and on fungal culture,
as well as an almost completely normal
appearance of the nail
d. Negative results on potassium hydroxide
(KOH) preparation and on fungal culture,
as well as a completely normal appearance
of the nail
8.All of the following currently are approved
by the US Food and Drug Administration for
the treatment of onychomycosis except:
a.Ciclopirox
b. Itraconazole
c.Laser therapy
d. Terbinafine pulse-dose therapy
9.The methods approved to date by the
US Food and Drug Administration for the
“temporary increase of clear nail in
onychomycosis” are:
a.Iontophoresis
b. Laser systems
c.Photodynamic therapy systems
d. Topical therapy
10.A potent inhibitor of CYP3A4, ____________
must be used with caution when treating
onychomycosis in patients with congestive
heart failure or other ventricular
dysfunction.
a.Ciclopirox
b. Fluconazole
c.Itraconazole
d. Terbinafine
Seminars in Cutaneous Medicine and Surgery
Update on Onychomycosis: Effective Strategies for Diagnosis and Treatment
CME Evaluation Form
Original Release Date: June 2013 • Most Recent Review Date: June 2013
Expiration Date: June 30, 2015 • Estimated Time to Complete Activity: 2.5 hours
To get instant CME credits online, sign in to the Web site at http://uofl.me/onycho13. Upon successful completion of the
online assessments, you can download and print your certificate of credit. If you have any questions or difficulties, please
contact the University of Louisville School of Medicine Continuing Medical Education office at [email protected].
EVALUATION FORM
We would appreciate your answering the following questions in order to
help us plan for other activities of this type. All information is confidential.
Please print.
Name:_____________________________________________________
Specialty:__________________________________________________
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o Other __________________________________________________
Affiliation:__________________________________________________
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Signature:__________________________________________________
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I verify that I have spent _____ hour(s)/_____ minutes of actual time
working on this CME activity. No more than 2.5 CME credits will be
issued for this activity.
COURSE EVALUATION: Gaps
Did participating in this educational activity improve your
COMPETENCE in the professional practice gaps that are listed
on the left?
Strongly Agree
1
Agree
2
Somewhat Agree
3
Disagree
4
Strongly Disagree
5
Please elaborate on your answer.____________________________
______________________________________________________
______________________________________________________
Did participating in this educational activity improve your
PERFORMANCE in the professional practice gaps that are listed
on the left?
Strongly Agree
1
Agree
2
Somewhat Agree
3
Disagree
4
Strongly Disagree
5
Please elaborate on your answer.____________________________
______________________________________________________
______________________________________________________
Please identify a change that you will implement into practice as
a result of participating in this educational activity (new protocols,
different medications, etc).
______________________________________________________
______________________________________________________
This activity was created to address the professional practice gaps listed
below. Please respond regarding how much you agree or disagree that
the following gaps were met:
• Clinicians do not adequately treat onychomycosis. Many
clinicians regard onychomycosis as a condition that is principally
cosmetic in nature and therefore do not treat appropriately.
• Clinicians outside the podiatry specialty are not utilizing
current literature on onychomycosis diagnosis and treatment.
Because onychomycosis traditionally has been managed by
podiatrists and, less so, by dermatologists, many clinicians in
other specialties and general practice have considered definitive
diagnosis and treatment of this infection to be outside the
purview of their practices.
• Physicians are not identifying new medications and other
therapeutic modalities for effective and safe treatment of
onychomycosis.
How certain are you that you will implement this change?
Did participating in this educational activity improve your
KNOWLEDGE in the professional practice gaps that are
listed above?
Do you think the articles were without commercial bias?
m Yes
Strongly Agree
1
Agree
2
Somewhat Agree
3
Disagree
4
Strongly Disagree
5
Please elaborate on your answer.____________________________
______________________________________________________
______________________________________________________
Strongly Agree
1
Agree
2
Somewhat Agree
3
Disagree
4
Strongly Disagree
5
What topics do you want to hear more about, and what issue(s) in
your practice will they address?______________________________
______________________________________________________
______________________________________________________
Were the patient recommendations based on acceptable practices
in medicine? m Yes m No
If no, please explain which recommendation(s) were not based on
acceptable practices in medicine.____________________________
______________________________________________________
______________________________________________________
m No
If no, please list the article(s) that was/were biased.______________
______________________________________________________
______________________________________________________
The University of Louisville thanks you for your participation in this CME activity.
All information provided improves the scope and purpose of our programs
and your patients’ care.
© 2013 Global Academy for Medical Education, LLC. All Rights Reserved.