Oral Isotretinoin for Acne: A Review of Published Guidelines From Europe, Canada, and the US

A series of recommendations for the treatment of acne with oral isotretinoin has been compiled in a review published in the Journal of the European Academy of Dermatology and Venereology. Using current guidelines and recently published consensus articles, investigators from Greece, Italy, and Germany described the current recommendations for isotretinoin daily dose, treatment length, and safety precautions.

Investigators assessed published guidelines and consensus articles published between 2012 and 2019 in English or French. Recommendations for 10 common clinical questions were compiled, including questions regarding recommended isotretinoin dose, appropriate isotretinoin indications, and pregnancy prevention. Overall, clinical practice guidelines from France, Canada, the United States, and Europe were included. Publication dates ranged from 2015 to 2017. The US guidelines were authored by the American Academy of Dermatology; the French, Canadian, and European guidelines were each developed by multidisciplinary panels of experts. Two international consensus articles published in 2016 and 2018, respectively, were included. A 2013 publication from the US regarding pediatric acne was also selected for review.

Guidelines varied significantly in the classification criteria for “severe” acne. Although lesion morphology was commonly used in acne diagnosis, facial involvement and erythema were inconsistently mentioned. Some guidelines endorsed oral isotretinoin as a first-line therapy for acne, and others suggested isotretinoin only after the failure of antibiotics and topical therapy. Overall, a single definition for “severe” acne was unavailable. Across most guidelines, isotretinoin treatment was recommended only for patients 12 years of age or older, as insufficient evidence exists for pediatric use. Recommended daily dosing ranged from 0.3-0.5 mg/kg in the European guidelines to up to 1.0 mg/kg in the US guidelines. The European guidelines suggested a treatment duration of at least 6 months, although another consensus article recommended 16 to24 weeks. All guidelines emphasized the necessity of pregnancy prevention measures. The European, French, and US guidelines recommended that clinicians monitor patients for symptoms of depression. Treatment aspects that were inconsistently addressed in guidelines included appropriate age at administration, recommended cumulative dose, timing of elective surgical procedures, recommendations for preventing acne flares, appropriate laboratory monitoring, and the association of isotretinoin with irritable bowel disease. 

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A limitation of the study is the use of different classification systems for acne across guidelines.

Per this review, guidelines for oral isotretinoin treatment varied significantly across countries. To approach international consensus, a standardized acne classification system should be developed. “The differences in recommendations for acne management…underline that unanswered clinical questions still exist and that there is room for standardization and further improvement of guidelines,” investigators wrote.

Disclosure: One study author declared affiliations with the pharmaceutical industry.

Please see the original reference for a full list of authors’ disclosures.

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Dessinioti C, Zouboulis CC, Bettoli V, Rigopoulos D. Comparison of guidelines and consensus articles on the management of patients with acne with oral isotretinoin [published online April 11, 2020]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.16430