Efficacy and Adverse Events of Oral Isotretinoin for Acne: A Systematic Review

Abstract

Despite many years of clinical use of isotretinoin, a comprehensive review of evidence for isotretinoin therapy in acne patients is lacking. We searched MEDLINE, EMBASE, Cochrane Central, relevant webpages and bibliographies for randomized controlled trials for acne evaluating isotretinoin vs control (placebo or other therapy). Data were extracted and summarized descriptively. Eleven trials were identified (total n=760 patients randomized), containing mostly males. Mean treatment ages ranged from 18 to 47.9 years and participants generally had moderate-severe acne. Across all trials, isotretinoin therapy reduced acne lesion counts by a clinically relevant amount, and always by a greater amount than control, which were either placebo (n=2 studies), oral antibiotics (n=7 studies), or other control (n=2 studies). Across trials with an overall low risk of bias, 2/3 demonstrated statistically significant differences between isotretinoin and control. The frequency of adverse events was twice as high with isotretinoin (n=751 events) compared to control (n=388 events). More than half of all adverse events were dermatologic and related to dryness. Adverse events from isotretinoin causing participant withdrawal from trials (n=12 patients) included Stevens-Johnson Syndrome, cheilitis, xerosis, acne flare, photophobia, elevated liver enzymes, decreased appetite, headaches and depressed mood. This review suggests that isotretinoin is effective in reducing acne lesion counts, but adverse events are common. PROSPERO CRD42015025080.

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