ACNE GUIDELINES: Management of Acne Vulgaris: Clinical Recommendations & Isotretinoin Position Statement. American Academy of Dermatology

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1 O ACNE GUIDELINES: Management of Acne Vulgaris: Clinical s & Isotretinoin Position Statement American Academy of Dermatology

2 s s for systems for the grading and classification of acne Clinicians may find it helpful to use a consistent classification/grading scale (encompassing the numbers and types of acne lesions as well as disease severity) to facilitate therapeutic decisions and assess response to treatment. Grading/classification system B II s for microbiologic and endocrinologic testing Routine microbiologic testing is unnecessary in the evaluation and management of patients with acne. Those who exhibit acne-like lesions suggestive of gram-negative folliculitis may benefit from microbiologic testing. Routine endocrinologic evaluation (e.g., for androgen excess) is not indicated for the majority of patients with acne. Laboratory evaluation is indicated for patients who have acne and additional signs of androgen excess. In young children this may be manifested by body odor, axillary or pubic hair and clitoromegaly. Adult women with symptoms of hyperandrogenism may present with recalcitrant or late-onset acne, infrequent menses, hirsutism, male or female pattern alopecia, infertility, acanthosis nigricans and truncal obesity. Microbiologic testing B II Endocrinologic testing A I s for topical therapy Topical therapy is a standard of care in acne treatment. Topical retinoids are important in acne treatment. Benzoyl peroxide and combinations with erythromycin or clindamycin are effective acne treatments. Topical antibiotics (e.g., erythromycin and clindamycin) are effective acne treatments. However, the use of these agents alone can be associated with the development of bacterial resistance. Salicylic acid is moderately effective in the treatment of acne. Azelaic acid has been shown to be effective in clinical trials, but its clinical use compared to other agents has limited efficacy according to experts. Data from peer-reviewed literature regarding the efficacy of sulfur, resorcinol, sodium sulfacetamide, aluminum chloride, and zinc are limited. Employing multiple topical agents that affect different aspects of acne pathogenesis can be useful. However, it is the opinion of the work group that such agents not be applied simultaneously unless they are known to be compatible. Retinoids A I Benzoyl peroxide A I Antibiotics A I Other agents A I

3 s s for systemic antibiotics Systemic antibiotics are a standard of care in the management of moderate and severe acne and treatment-resistant forms of inflammatory acne. Doxycycline and minocycline are more effective than tetracycline and there is evidence that minocycline is superior to doxycycline in reducing P. acnes. Although erythromycin is effective, use should be limited to those who cannot use the tetracyclines (i.e., pregnant women or children under 8 years because of the potential for damage to the skeleton or teeth). The development of bacterial resistance is also common during erythromycin therapy. Trimethoprim-sulfamethoxazole and trimethoprim alone are also effective in instances where other antibiotics cannot be used. Bacterial resistance to antibiotics is an increasing problem. The incidence of significant adverse effects with antibiotic use is low. However, adverse effect profiles may be helpful for each systemic antibiotic used in the treatment of acne. Tetracyclines A I Macrolides A I Trimethoprimsulfamethoxazole A I s for hormonal agents Estrogen-containing oral contraceptives can be useful in the treatment of acne in some women. Oral antiandrogens such as spironolactone and cyproterone acetate can be useful in the treatment of acne. While flutamide can be effective, hepatic toxicity limits its use. There is no evidence to support the use of finasteride. There are limited data to support the effectiveness of oral corticosteroids in the treatment of acne. There is a consensus of expert opinion that oral corticosteroid therapy is of temporary benefit in patients who have severe inflammatory acne. In patients who have well-documented adrenal hyperandrogenism low-dose oral corticosteroids may be useful in treatment of acne. Contraceptive Agents A I Spironolactone B II Antiandrogens B II Oral Corticosteroids B II

4 s s for dietary restriction Dietary restriction (either specific foods or food classes) has not been demonstrated to be of benefit in the treatment of acne. Effect of diet B II s for isotretinoin Oral isotretinoin is approved for the treatment of severe recalcitrant nodular acne. It is the unanimous opinion of the acne workgroup that oral isotretinoin is also useful for the management of lesser degrees of acne that are treatment-resistant or for the management of acne or that is producing either physical or psychological scarring. Oral isotretinoin is a potent teratogen. Because of its teratogenicity and the potential for many other adverse effects, this drug should be prescribed only by those physicians knowledgeable in its appropriate administration and monitoring. Female patients of child-bearing potential must only be treated with oral isotretinoin if they are participating in the approved pregnancy prevention and management program (ipledge). Mood disorders, depression, suicidal ideation, and suicides have been reported in patients taking this drug. However, a causal relationship has not been established. Please see the American Academy of Dermatology s full position statement on the use of isotretinoin at the end of this booklet. Isotretinoin A I s for miscellaneous therapy Intralesional corticosteroid injections are effective in the treatment of individual acne nodules. There is limited evidence regarding the benefit of physical modalities including glycolic acid peels and salicylic acid peels. Intralesional steroids C III Chemical peels C III Comedo removal C III s for complementary therapy Herbal and alternative therapies have been used to treat acne. Although these products appear to be well tolerated, very limited data exist regarding the safety and efficacy of these agents. Herbal agents B II Psychological approaches C III Hypnosis/biofeedback B II

5 American Academy of Dermatology Position Statement on the Use of Isotretinoin 1. The Association is committed to the safe and responsible use of Isotretinoin. Isotretinoin is FDA approved for and generally considered by dermatologists to be the most effective treatment for severe recalcitrant nodular acne. The effectiveness of systemic isotretinoin therapy in the treatment of acne has been demonstrated in randomized, double blinded clinical studies. It is known to effectively reduce acne and lead to a reduction in scarring The Association recognizes there is sufficient evidence for the use of isotretinoin in severe forms of acne, particularly (but not limited to) severe recalcitrant nodular acne or acne which has proven refractory to other forms of therapy. Assessment of severity includes the impact of the disease on the patient, both physical and psychological The Association recognizes that isotretinoin has been used off-label in the treatment of conditions such as disorders of cornification and in chemoprevention of skin cancer in high risk individuals. The Association believes such off-label uses are permitted under the FDA s practice of medicine exception to its drug approval process. Physicians considering the use of isotretinoin in such off-label indications should make the patient aware that off-label usage has not been specifically approved by FDA. 4. The Association promotes compliance with the manufacturer-sponsored and FDA-approved risk management program for prescribing isotretinoin (ipledge). It opposes on-line Internet dispensing, sharing, or use without physician supervision, because these activities do not provide for sufficient patient education about isotretinoin risks and do not require participation in the ipledge program 5. The Association supports continuing education for physicians, their office staff, allied medical personnel, and patients on the potential risks connected with the use of isotretinoin. In particular, prescribers, patients, pharmacies, and manufacturers must comply with the ipledge risk management program as outlined on the ipledge web site ( to prevent fetal exposure during treatment with isotretinoin A correlation between isotretinoin use and depression/anxiety symptoms has been suggested but an evidence-based causal relationship has not been established. Other studies give evidence that treatment of acne with isotretinoin was accompanied by improvement of both depressive and anxiety symptoms, as well as improved quality of life of patients with acne Current evidence is insufficient to prove either an association or a causal relationship between isotretinoin use and inflammatory bowel disease (IBD) in the general population. 7, 8 While some recent studies have suggested such a relationship 9,10, further studies are required to conclusively determine if the association or causal relationship exists and/or whether IBD risk may be linked to the presence of severe acne itself. 8. The Association concludes that the prescription of isotretinoin for severe nodular acne continues to be appropriate as long as prescribing physicians are aware of the issues related to isotretinoin use, including IBD or psychiatric disturbance, and educate their patients about these and other potential risks. Physicians also should monitor their patients for any indication of IBD and depressive symptoms.

6 ReFERENCES 1. Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC, Thiboutot DM, Van Voorhees AS, Beutner KA, Sieck CK, Bhushan R. American Academy of Dermatology. Guidelines of care for acne vulgaris management. J Am Acad Dermatol 2007 Apr;56(4): Strauss JS, Rapini RP, Shalita AR et al. Isotretinoin therapy for acne: results of a multicenter doseresponse study. J Am Acad Dermatol 1984; 10: Strauss JS, Leyden JJ, Lucky AW et al (2001) Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin. J Am Acad Dermatol 45: Goulden V, Clark SM, Mcgeown C, Cunliffe WJ (1997) Treatment of acne with intermittent isotretinoin. Br J Dermatol 137: Hahm BJ, Min SU, Yoon MY, Shin YW, Kim JS, Jung JY, Suh DH. Changes of psychiatric parameters and their relationships by oral isotretinoin in acne patients. J Dermatol May;36(5): Kaymak Y, Taner E, Taner Y. Comparison of depression, anxiety and life quality in acne vulgaris patients who were treated with either isotretinoin or topical agents. Int J Dermatol Jan;48(1): Bernstein CN, Nugent Z, Longobardi T, Blanchard JF. Isotretinoin Is Not Associated with Inflammatory Bowel Disease: A Population-Based Case-Control Study. Am J Gastroenterol Nov;104(11): Crockett SD, Gulati A, Sandler RS, Kappelman MD.A causal association between isotretinoin and inflammatory bowel disease has yet to be established. Am J Gastroenterol Oct;104(10): Reddy D, Siegel CA, Sands BE, Kane S. Possible association between isotretinoin and inflammatory bowel disease. Am J Gastroenterol. 2006;101: Crockett SD, Porter CQ, Martin CF, Sandler RS, Kappelman MD. Isotretinoin Use and the Risk of Inflammatory Bowel Disease: A Case-Control Study. Am J Gastroenterol Mar 30 online American Academy of Dermatology Correspondence: PO Box 4014 Schaumburg, Illinois Toll-free: SKIN (7546) International: Fax: For more information: Copyright 2012 American Academy of Dermatology. All rights reserved. 11_746_C