Download Acne Vulgaris 2016

Acne Vulgaris
Megan D. P. Cooper, RPh, PharmD
Spring 2016
Lecture Objectives
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Describe the etiology, exacerbating factors, and pathophysiology of acne vulgaris
Describe the clinical presentation of acne vulgaris
Discuss the pharmacology, side effects, drug interactions, and proper dosing of commonly used
medications for acne vulgaris
Given a patient case, select an appropriate treatment regimen, monitoring parameters and patient
related consultation recommendations considering the patient's diagnosis and unique
characteristics
Assess a patient’s pharmacotherapeutic regimen for safety and efficacy using clinical signs,
symptoms and laboratory data
Counsel patients on non-pharmacologic modalities to treat acne vulgaris
Definition of disease:
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Chronic inflammatory disorder of the pilosebaceous unit
Most notable for open and closed comedones and inflammatory lesions (papules, pustules,
nodules)
Etiology
FOUR primary factors involved in the formation of acne lesions:
1. Increased sebum production
o Sebum production in the sebaceous glands is primarily driven by androgenic activity,
and the acne affected pilosebaceous units seem to have a hyper-responsiveness to
circulating androgens.
o Testosterone is the predominant androgen, is increased in acne and capable of enhancing
sebaceous gland activity (androgen stimulation is enhanced at puberty)
2. Follicular hyperproliferation and abnormal desquamation
o Follicular hyperkeratinization and abnormal corneocyte desquamation lead to follicular
obstruction. This, in combination with the androgen-stimulated increase in sebum
production, promotes the formation of the microcomedo, the earliest stage of acne.
3. Bacterial growth
o Propionibacterium acnes: a gram-positive anaerobe, resides in the follicle as normal
flora, however the mix of “trapped” keratinocytes and sebum provide an environment for
overgrowth
4. Inflammation
o May be a consequence of increased sebum production, keratinocyte sloughing and
bacterial growth
o P.acnes may trigger inflammatory acne lesions by producing biologically active
mediators and promoting proinflammatory cytokine release
Pathophysiology:
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Follicular canal contents include keratinocytes, P.acnes, and free fatty acids
The microcomedo enlarges to form a comedo as lipids, bacteria, and desquamated corneocytes
accumulate. P. acnes can proliferate in this environment
The comedo “plugs” the pilosebaceous follicle → the follicular canal widens and an increase in
cell production is seen → sebum mixes with excess loose cells in the follicular canal to form a
keratinous plug, which results in a “blackhead” or open comedo.
The open comedo has a brown or black appearance due to melanin accumulation.
Inflammation or trauma to the follicle may lead to formation of a “whitehead” or closed comedo.
Closed comedones are important clinically because they can become larger, inflammatory lesions
secondary to P. acnes activity.
Exacerbating factors or Risk Factors:
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Genetic predisposition
Oil based cosmetics or skin creams
Occlusive hair dyes
Repetitive mechanical trauma by over-scrubbing skin
Occlusive clothes (bras, helmets, turtlenecks, shoulder pads, etc)
Excessive rubbing of skin or picking at skin
High humidity
Heavy sweating
Diet – controversial; not scientifically proven – high glycemic index vs low glycemic index diet
Psychological stress – proven scientifically
Occupational exposures to dirt, vaporized cooking oils or grease
Androgens
Azathioprine
Barbituates
Corticosteroids
Corticotropin
Cyclosporine
Medications known to cause acne:
Disulfiram
Isoniazid
Lithium
Phenytoin
Psoralens
Vitamins B2, B6, B12
Additional Testing
Usually not necessary unless attempting to rule out causes for acne-like lesions or patients with suspected
hyperandrogenism
o Endocrinologic testing:
o Testosterone, free
o Dehydroepiandrosterone sulfate
o Leutinizing hormone
o Follicle-stimulating hormone
Clinical Presentation:
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Lesions typically occur on the face, back, upper chest & shoulders because this is where
sebaceous glands are most predominant.
Usually present with a mixture of lesions in various stages of development, and may include
noninflammatory and inflammatory lesions, scars, and residual hyperpigmentation. The presence
of 5-10 comedones is usually diagnostic:
o Comedones
o Pustules
o Papules
o Nodules
o Cysts
Non-inflammatory lesions: consist of open and closed comedones
o Open comedo (blackhead): plug of sebum, keratinocytes, and microorganisms blocking a
dilated hair follicle opening
o Closed comedone (whitehead): a similar plug blocking a closed hair follicle opening
Inflammatory lesions: consist of papules, pustules and maybe nodules
Scars are a common result of inflammatory acne lesions
Acne Severity
Mild
Moderate
Severe
Predominant Lesions
Non-inflammatory lesions
consisting of few to numerous open
and closed comedones
Inflammatory papules and pustules
with some non-inflammatory
lesions described above
Inflammatory and noninflammatory lesions described
above with scarring usually present
Papules
Possible
Pustules
Possible
Nodules
None
Numerous
Numerous Few
Extensive
Extensive
Scarring
None
Possible
Extensive Extensive
Treatment
Patient Considerations
Deciding on the appropriate course of treatment for an individual patient requires a comprehensive
assessment that includes:
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Nonpharmacological and Alternative therapies
 None has proven drastically effective
 Herbal and alternative therapies (primarily tea tree oil) is well tolerated and effective but has
slower onset of action than other topical therapies
 Dietary restriction has not demonstrated benefit
 Cleanse skin with noncomedogenic soap twice daily
 Avoid vigorously scrubbing lesions
 Do not pick or squeeze lesions
 Avoid occlusive clothing or head gear, resting face on hands, oil based cosmetics
Pharmacologic Treatment
Most treatments reduce or prevent new eruptions, and during the first few weeks of therapy acne may
worsen existing lesions
 It takes _____ weeks for a microcomedo to mature. Thus, any therapy must be continued beyond
this duration in order to assess efficacy.
 Initial treatment is aimed at reducing lesion count and duration of therapy varies depending on
severity and treatment response
o Oily skin – use gels, solutions, lotions
o Normal skin – use gels, solutions, lotions, creams
o Dry skin – use lotions and creams
o Solutions can be drying but are useful for use over large areas of skin
o Foams are good for hair-bearing areas
 Topical therapy is primarily used in mild to moderate acne
 Systemic therapy is required in patients with moderate to severe acne
TOPICAL THERAPY (mild to moderate acne)
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Topical retinoids (TRs):
 tretinoin (Atralin™; Avita®; Renova®; Retin-A® Micro; Retin-A®; Tretin-X™)
 adapalene (Differin® XP; Differin®)
 tazarotene (Avage™; Tazorac®)
 COMBO PRODUCTS:
 adapalene 0.1% + benzoyl peroxide 2.5% gel (Epiduo®)
 tretinoin 0.025% + clindamycin 1.2% gel (Veltin®, Ziana®)
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Safety
 “Photosensitivity” and sunburn risk
 Tazarotene Category X; the others are C
Tolerability
 All agents cause skin irritation, dryness, flaking of skin, but microsphere
formulations of tretinoin and 3rd generations are more tolerable
Efficacy
 Generally recommended as first line agents for comedogenic and mild to
moderate inflammatory acne
 Preferred agents for acne maintenance to minimize antibiotic use
 Reduces follicular occlusion and halts microcomedo formation
 Effective as monotherapy but synergistic when used in combo with
topical antibiotics and benzoyl peroxide with minimal to no increased
side effects
 May take up to 3 months to see an effect, and therapy should be
continued until no new lesions develop
 Accelerates resolution of post-inflammatory hyperpigmentation
 May enhance penetration of other topical acne meds
 Comparative trials do not definitively advocate for one agent over
another, however adapalene tends to be the best tolerated; tazarotene
may be more effective but is most irritating
Preference/Pearls
 Transient worsening of symptoms initially but usually resolves within 24 weeks with continued treatment
 Many dosage forms available: gels, creams, solutions; microsphere
formulation and liquid polymer forms are less irritating
Simplicity/Dosing
 Once daily application in the evening due to photoliability (except
adapalene)
Patient counseling points/additional info
 Due to preventative effect of TRs on acne, counsel patients to apply to
entire face, not as spot treatment of individual lesions.
 Skin should be dry at time of application
 Use at least SPF 15 sunscreen for outdoor activities
 Skin becomes extremely sensitive to weather extremes (wind, cold)
 Counsel appropriately when using concomitantly with other
photosensitizing meds
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Benzoyl Peroxide 2.5%-10% (BPO)
 Safety
 Photosensitivity and sunburn risk
 Tolerability
 Skin irritation, erythema, scaling, peeling, xerosis, stinging, tightening sensation,
burning, swelling, pruritus
 Can bleach hair, skin, and clothing
 Efficacy
 Efficacy seen with 2.5% and 5% concentrations with only minimal benefit when
increased to 10%. Increasing concentration leads to higher incidence of side
effects with minimal benefit.
 Useful for both comedonal and inflammatory acne
 Bactericidal against P.acnes, increases epithelial sloughing, comedolytic
 Comparable efficacy to antibiotics without causing bacterial resistance
 Recommended as one of the first line agents for acne
 Useful as monotherapy but more effective when used in combo with other topical
agents
 Preference/Pearls
 Available Rx and OTC; many dosage forms available: gels, lotions, creams,
pads, masks, cleansers, solutions, soap
 When used in combo with oral or topical antibiotics, decreases and prevents
antibacterial resistance
 BPO is most cost effective agent in acne management
 Simplicity/Dosing
 Twice daily application
 Patient counseling points/additional info
 Advise patient to wash away drug after a few hours when first initiating therapy
to help skin grow to tolerate it
 Do not use simultaneously with topical tretinoin and tazarotene because BPO
oxides them and makes them less effective. If using both agents, use BPO in the
morning, and TR at night.
 Apply to dry skin to minimize irritation
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Azelaic acid
 Azelex®--20% Cream---FDA approved for acne vulgaris
 Finacea®--15% Gel----FDA approved for acne rosacea
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Safety
 Avoid contact with eyes or mucous membranes
Tolerability
 Skin irritation is reported in a few individuals
 Isolated reports of hypopigmentation with use
Efficacy
 Possesses antimicrobial, comedolytic and mild anti-inflammatory properties
 Can improve acne induced post-inflammatory hyperpigmentation
 Effective for both mild-moderate inflammatory acne and comedonal acne
Preference/Pearls
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 Considered second or third line agent in the treatment of mild to moderate
inflammatory acne and comedonal acne in patients who cannot tolerate benzoyl
peroxide or topical retinoids
 Has a hypopigmentation effect that may be effective in treating postinflammatory hyperpigmentation resulting from acne
 Has no likelihood of bacterial resistance, systemic adverse effects or
photosensitivity
Simplicity/Dosing
 Once daily application is just as effective as twice daily application
 Use in combo with other agents is more effective than using it alone
Patient counseling points/additional info
 Apply to clean dry skin
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Dapsone 5% gel (Aczone®)
 Safety
 Increased risk of hemolytic anemia in patients with glucose-6-phosphate
dehydrogenase (G6PD) deficiency taking ORAL dapsone, but this is not a
problem when used TOPICALLY
 Testing for G6PD deficiency is NOT necessary if using topical form
 Questionable decrease in hemoglobin with topical use—caution in those with
anemia---monitor
 Photosensitivity
 Tolerability
 Temporary yellow to orange skin and hair discoloration may occur if used
concurrently with BPO; if both agents are needed, apply one in the morning and
the other in the evening and wash face between applications
 Skin oiliness, peeling, dryness, erythema
 Efficacy
 Mechanism not entirely understood, but has anti-inflammatory and antimicrobial
properties
 Useful for mild-moderate inflammatory and comedonal acne
 Greatest improvement is seen in inflammatory lesions
 Preference/Pearls
 Is a sulfone derivative, NOT sulfonamide—therefore topical dapsone is NOT
contraindicated in patients with sulfa allergy
 Is a newer agent, and is still undergoing studies evaluating long-term efficacy as
monotherapy and safety when combined with other agents
 Simplicity/Dosing
 Twice daily application for at least 12 weeks
 Patient counseling points/additional info
 Apply small (pea-size) amount to skin and gently rub in
 Patients may notice gritty appearance to particles after application
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Salicylic Acid
 Safety
 Risk of salicylate toxicity with repeated widespread use on highly permeable
(inflamed or abraded) skin
 Tolerability
 Mild skin irritation
 Efficacy
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 Keratolytic, comedolytic, anti-inflammatory, bacteriostatic and fungistatic
properties
 Considered 2nd line agent because comedolytic properties are less potent than
TRs and BPO; generally used when patients cannot tolerate TRs or BPO due to
skin irritation
Preference/Pearls
Simplicity/Dosing
 Many dosage forms: cloths, cleansers, cream, foam, gel, liquid, lotions, soaps
 Available OTC and Rx
 Dosed once to three times daily depending on product
 Effective concentrations for acne are 0.5%-2%
Patient counseling points/additional info
 Apply to clean dry skin
 If using cleanser, medication is only active as long as product is on skin.
Topical Antibiotics (clindamycin or erythromycin)
 Erythromycin 2% gel, solution
 Clindamycin 1% gel, solution, lotion, foam, pledget
 COMBO PRODUCTS:
 Clindamycin 1.2% + BPO 2.5% gel (Acanya®)
 Clindamycin 1% + BPO 5% gel (BenzaClin®)
 Clindamycin 1.2% + BPO 5% gel (Duac®)
 Clindamycin 1.2% + tretinoin 0.025% gel (Veltin®, Ziana®)
 Erythromycin 3% + BPO 5% gel (Benzamycin®)
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Safety
 Pseudomembranous colitis and hypersensitivity reactions have been rarely
reported (<1%) in patients using topical clindamycin
Tolerability
 Dry skin, erythema, itching, scaling or peeling
Efficacy
 Directly suppresses P.acnes
 MUST use in combination with BPO to minimize/prevent resistance; use as a
single agent is not recommended
 Efficacy is also increased with combined with BPO or TR
Preference/Pearls
 Recommended 2nd line because of concerns of increasing resistance to these
agents
Simplicity/Dosing
 Both agents are available in a combo product with BPO
 Clindamycin is available in combo with tretinoin
 Many dosage forms: gels, solution, foam, lotions
 Apply once or twice daily after facial cleansing
Patient counseling points/additional info
 If using topical clindamycin foam, dispense the dose into the cap or onto a cool
surface and then administer small amounts to the affected area
Other miscellaneous topical agents
 Sulfur and resorcinol have been used for years but evidence from peer-reviewed literature
supporting efficacy is lacking
 Aluminum chloride possesses antibacterial activity, but there is controversial evidence as to its
efficacy
 Topical zinc alone – ineffective
 Sulfacetamide – a topical antibiotic used in acne; data regarding effectiveness is limited; cannot
be used in sulfa-allergic patients
TOPICAL THERAPY: SUMMARY & CLINICAL PEARLS
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Topical therapy is a standard of care in mild to moderate acne treatment
Due to their high effectiveness, TRs are recommended 1st line for treatment and maintenance
BPO is also recommended as a first line agent and is the most cost effective due to OTC status
Combination of topical agents are more effective than any agent used alone
Topical abx are effective but must be used in combo with BPO to prevent bacterial resistance;
generally reserved for inflammatory acne
Salicylic acid is moderately effective in the treatment of acne (less effective than TRs and BPO)
Azelaic acid has usefulness in postinflammatory hyperpigmentation
It’s very effective to use multiple topical agents that affect different aspects of acne pathogenesis,
but be aware of compatibility between agents
SYSTEMIC THERAPY (moderate to severe acne)
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Oral antibiotics
 Tetracycline 250-500 mg po BID on empty stomach
 Doxycycline 100-200 mg po daily (without regard to meals)
 Minocycline 50mg po BID without regard to meals
 Solodyn® extended release minocycline dosed 1mg/kg/day
 Erythromycin 500mg po BID with food
 Clindamycin 150-300 mg po daily
 Trimethoprim-sulfamethoxazole 1 DS tab po BID
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Safety
 Tooth discoloration, enamel hypoplasia, and reduced bone growth in children
<8yo and pregnant women (tetracyclines)
 Fetal and infant toxicity (tetracyclines and sulfamethoxazole/TMP)
 Bone marrow suppression, SJS, TEN (sulfamethoxazole/TMP)
 Bacterial resistance, GI upset, pseudomembranous colitis (erythromycin,
clindamycin)
 Photosensitivity
Tolerability
 Nausea, vomiting, diarrhea, vaginal candidiasis
Efficacy
 Minocycline, doxycycline, tetracycline, erythromycin, clindamycin,
azithromycin, sulfamethoxazole/TMP are all efficacious for treating acne
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Place in therapy—reserve for treatment resistant inflammatory acne
AAD recommends reserving oral Abx for moderate to severe acne and limiting
duration of use when possible (experts recommend limiting use to 12-18 weeks)
 Improvement is generally seen in 6-10 weeks
Preference/Pearls
 Use BPO in combo with oral abx to decrease bacterial resistance
 Can also use oral abx in combo with TR to increase efficacy and to minimize use
of abx
 Minocycline appears more efficacious, followed by doxycycline and tetracycline,
respectively (CONTROVERSIAL)
 Minocycline is the least photosensitizing of the three tetracyclines but can cause
vertigo, skin discoloration, and lupus-like syndrome
 Save erythromycin for patient who are recommended against using tetracyclines
(pregnancy, <8yo)
 Very high bacterial resistance to erythromycin----for this reason not used
preferentially
 Sulfamethoxazole/TMP or TMP alone may be used for patients who cannot use
the above-mentioned abx (used rarely)
Simplicity/Dosing
 Once or twice daily dosing, depending on agent
 Oral abx are less expensive than other agents typically used for moderate to
severe acne
Patient counseling points/additional info
 May try probiotics or yogurt to minimize occurrence of vaginal candidiasis
 Tetracycline absorption is inhibited by food, dairy products, antacids and iron;
and must be taken on an empty stomach. Patients should take one hour prior to
eating or two hours after a meal
 Doxycycline and minocycline can be taken with food and drink (although still
separate with divalent cations), and doing so may reduce the GI side effects
Isotretinoin (Amnesteem®, Claravis™, Absorica®, Myorisan®, Zenatane®)
 Safety
 Highly teratogenic (pregnancy category X)— iPLEDGE™ program
 Suicidal ideations
 Pancreatitis
 Pseudotumor cerebri
 Relative contraindications: Hyperlipidemia, diabetes mellitus, severe
osteoporosis
 Significant adverse effects are numerous, frequent, and often dose related:
 Drying of the oral, nasal, and ocular mucosa – VERY common
 Chelitis and skin desquamation
 Elevated cholesterol & triglycerides – reversible upon dose reduction or drug d/c
 Dose is better absorbed with fatty good because it is a vitamin A
derivative, but the overall diet needs to be healthier because of the
hyperlipidemia concern
 Elevation of CPK, glucose
 Photosensitivity
 Pseudotumor cerebri
 Excess granulation tissue, scarring
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 Hepatomegaly with increased LFTs
 Bone abnormalities – decreased BMD, impairment of growth
 Arthralgias, myalgias, muscle stiffness and headaches
 Significant mood changes, depression, suicidal ideation and completed suicides
 Alopecia
 Hearing & vision impairment
 IBD
Efficacy
 Effectively reduces inflammatory lesions and acne cysts—the most effective
sebosuppressive agent
 Reserved for severe nodulocystic acne, treatment resistant acne, or acne resulting
in physical or psychological scarring
Preference/Pearls
 All AB rated in Orange Book EXCEPT Absorica BX
 Participation in iPLEDGE™ program a must for all patients
 Requires monthly pregnancy tests and commitment to use 2 forms of
contraception
 Any and all pregnancies need to be referred to a reproductive toxicity specialist
for evaluation
 Treat for up to 20 weeks and discontinue sooner if acne resolution is 70% or
greater
 Can only be prescribed by prescribers knowledgeable in its administration and
monitoring and must be registered with iPLEDGE program
 Relapse usually occurs within the first 3 years and is highest in those with truncal
acne and those receiving lower than the total recommended cumulative dose
 Acne may worsen initially during the first few weeks of treatment but can be
managed with short course of steroids
 Cannot donate blood during treatment or within one month of stopping the drug
Simplicity/Dosing/Monitoring parameters:
 Twice daily dosing
 Weight-based dosing (0.5 mg/kg/day in divided doses for first month, then
increased to 1 mg/kg/day in divided doses)
 Requires monthly monitoring of various adverse events (neurologic,
ophthalmologic, GI, metabolic)
 Monitor LFTs & lipids at baseline and at weeks 4 & 8.
 Must screen for psychiatric disorders and depression before and during treatment
 Monitor CPK, glucose, CBC with diff
Patient counseling points/additional info
 Participating in iPLEDGE™, avoiding pregnancy, regular/routine monitoring
should be continually reinforced
 Prescriptions should only be for 1-month supply and should be filled within 7
days of Rx date
 Oral retinoids carry same risk of sunburn than topical retinoids, so recommend
sunscreen for all patients during outdoor activities
 Do not use with tetracyclines or tigecycline – increases chance of pseudotumor
cerebri
 Increases clearance of carbamazepine
 Decreases effectiveness of oral contraceptives (hence the need for two forms of
birth control)
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More info about iPLEDGE™ Program: www.ipledgeprogram.com
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ALL patients (male and female), prescribing physicians, dispensing pharmacies, and
wholesalers & manufacturer must be registered
Pregnancy test (for all female patients of childbearing potential): Two negative tests
prior to beginning therapy (the second performed at least 19 days after the first test and
performed during the first 5 days of the menstrual period immediately preceding the start
of therapy); monthly tests to rule out pregnancy prior to refilling prescription.
Pregnancy tests must be done in CLIA certified lab and results must be submitted to
iPLEDGE™ before prescription authorization
Two forms of contraception must be used: initiated at least 1 month prior to therapy,
during the entire treatment course and continued for up to 1 month after discontinuing
treatment
Physicians must certify expertise in the diagnosis and treatment of acne, and knowledge
of the risk and severity of birth defects with isotretinoin
ACNE IN SPECIAL POPULATIONS & MISC ACNE
TREATMENTS:
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Post-inflammatory hyperpigmentation:
o DOC – TRs or Azelaic acid
o Alternative: Hydroquinone (Esoterica®, Lustra®---many brand name products)
 Available in 2% formulations OTC
 Available in 3-4% formulations as Rx
o Depigmenting agent that acts by inhibiting melanin production
o Dosed BID
o May cause grayish discoloration of skin at sites of application (uncommon)
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Pregnancy
o Consider risk vs benefit
o Isotretinoin and tazarotene Category X!!! Absolute contraindication!
o Clindamycin, erythromycin, azelaic acid---Category B
o Benzoyl peroxide—Category C
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Pediatrics/Adolescents
o Preadolescent acne (7-12 years) is common and may precede other signs of pubertal
maturation
o Pathogenesis and treatment is similar to older adolescents and adults
o General approach is to use the least aggressive regimen that is effective while avoiding
regimens that encourage the development of bacterial resistance.
 Nonpharmacologic measures and twice daily cleaning regimens
 OTC products including low strength BPO, salicylic acid, sulfur, resorcinol,
sodium sulfacetamide as possible ingredients
 TRs—clinical trials include 12-18 yrs old
 Tretinoin gel 0.05% (Atralin®) FDA approved in >10yrs old
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Adapalene and BPO (Epiduo®) indicated for ages 9 and older
Adapalene gel, tretinoin gel, tretinoin microsphere gel have been investigated in
both open label and blinded studies in children < 12 yrs (currently are used offlabel in this age group)
AAD endorses use of TRs for all types and severities of acne in children and
adolescents of all ages
Topical Abx OK if used in combo with BPO
Reserve oral Abx for moderate to severe inflammatory acne: prefer doxycycline
or minocycline UNLESS < 8yrs old
Isotretinoin for severe, scarring, and/or refractory acne in adolescents (>13-Grade
A recommendation); preadolescents (Grade C)
Reserve use of oral contraceptives for acne not associated with endocrinologic
pathology until 1 year after onset of menses
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Oral contraceptives
 Safety/Considerations
 VTE risk, breast CA history/family history, cerebrovascular disease, smoking in
patients >35yo
 Tolerability
 Abnormal vaginal bleeding, cycle disruption
 Headaches
 Abdominal cramping
 Nausea, weight gain, bloating, breast tenderness, lower extremity edema,
decreased libido, increased appetite
 Efficacy
 Reduces severity of inflammatory and comedonal acne
 Can take up to 3-6 months to see a significant effect
 Preference/Pearls
 Low to moderate dose of ethinyl estradiol (20-35 mcg) appears to be target dose
 Good choice in women with excess production of androgen, severe seborrhea,
androgenic alopecia, late-onset acne
 Use 2nd or 3rd generation progestins, as they have the least androgenic activity
(norgestimate, norethindrone acetate, desogestrel)
 DO NOT use 2nd generation progestins (levonorgestrel or norgestrel) as
these have the MOST androgenic activity.
 Drosperinone has antiandrogenic activity
 Simplicity/Dosing
 Once daily dosing
 May be used to treat other conditions including dysmenorrhea, PCOS,
menorrhagia
 May be used to prevent pregnancy in those taking isotretinoin, and can help acne
at same time
 Patient counseling points/additional info
 Patients need to have annual physical exams while using OCs, including PAP
smear and breast exams
 Smoking cessation counseling for patients who use cigarettes infrequently
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Oral spironolactone
 Safety
 Hyperkalemia- must monitor potassium
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 Monitor blood pressure
 Caution in renal impairment
Tolerability
 Gynecomastia in men
 In women, menstrual irregularity, breast tenderness, headache, fatigue
Efficacy
 Anti-androgen that blocks androgen receptors at higher doses
 May require 3-6 months to see significant effect
Preference/Pearls
 Typically reserved for patients with hyperandrogenism or PCOS
Simplicity/Dosing
 Dosed at 50-200 mg per day
Patient counseling points/additional info
 Counsel on importance of monitoring BP and potassium levels
 Caution in concomitant use of other meds that increase potassium
Oral corticosteroids
o Limited data to support effectiveness but may be of temporary benefit in those with
severe inflammatory acne; only use very short bursts of high dose
o Good choice for those with adrenal hyperandrogenism; use low doses
o Generally used to reduce flare ups, especially when associated with tretinoins and
isotretinoin
SYSTEMIC THERAPY: SUMMARY & CLINICAL PEARLS
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Systemic therapy is typically reserved for moderate to severe acne when topical therapies in
combination have failed
Because of bacterial resistance concerns, BPO should always be used in combination with oral
antibiotics, and duration of use should be limited to 12-18 weeks
Combining oral antibiotics with TRs improves efficacy and limits duration of abx use
Estrogen containing OCs can be useful in some women (regardless of acne severity)
Oral antiandrogens such as spironolactone can be useful in the treatment of acne, especially in
those patients with hyperandrogenism
There is limited data supporting the use of oral corticosteroids, but there is consensus expert
opinion that steroids offer temporary benefit in patients who have severe inflammatory acne,
well-documented adrenal hyperandrogenism, and to reduce flare-ups associated with TRs and
oral isotretinoin.
TREATMENT ALGORITHM
Mild comedonal
acne
Mild to moderate
inflammatory acne
Moderate to severe
inflammatory acne
Severe nodular
acne
1. Topical retinoid + oral Abx + benzoyl peroxide (1st
line option) (combos more effective than monotherapy)
1. Topical Retinoids (TR) or
2. Benzoyl peroxide (BPO) or
3. Topical Salicylic acid or azelaic
acid (2nd line agents)
Generally monotherapy will
suffice
2. Consider adding oral isotretinoin if <50% improvement
after 6 months of tx with oral Abx
3. OR consider adding antiandrogen or corticosteroid in
select patients or those unwilling to take oral isotretinoin
Any combination of topical therapies
(combos more effective than
monotherapy)
1. TR + BPO (1st line agents)
2. Topical Abx + BPO +/- TR
1. Oral isotretinoin
2. Oral Abx + topical retinoid +
benzoyl peroxide (but not as effective
as the above)
If any combination topical therapy is
ineffective, consider oral antibiotics
For acne maintenance: TR for mild acne
TR +/- BPO for moderate-severe acne
For women, regardless of severity who desire contraception: antiandrogenic oral contraceptives
For hyperandrogenic patients: consider spironolactone or corticosteroids (in add’n to standard therapy)
For TR and isotretinoin flare, or highly inflammatory acne: corticosteroids
For post-inflammatory hyperpigmentation: TR or azelaic acid
Resources:
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Eichemfield LF, Krakowski AC, Piggott C, Del Rosso J, Baldwin H. et al. Evidence-Based Recommendations for the
Diagnosis and Treatment of Pediatric Acne. Pediatrics 2013; 131;S163 DOI: 10.1542/peds.2013-0490B
Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, et al. Guidelines of care for acne vulgaris management. J Am Acad
Dermatol, 2007;56:651-63 DOI: 10.1016/j.jaad.2006.08.048
www.fda.gov for drug information