1. Patients receiving 220 mg/kg or more of oral isotretinoin had a significantly decreased risk of acne relapse at 1 year after treatment completion, compared to those receiving <220 mg/kg.
2. The only adverse effect that was significantly more common in the high-dose treatment group was that of skin irritation (“retinoid dermatitis”).
Evidence Rating Level: 2 (Good)
Study Rundown: Although there is strong evidence supporting the fact that oral isotretinoin is the most effective treatment option for severe nodular-cystic acne vulgaris, the literature reveals conflicting opinions regarding ideal dosing regimens. While 120 to 150 mg/kg is the traditional cumulative dosing regimen, some newer studies present arguments for both lower and higher doses to decrease rates of relapse, retrial and adverse effects. This study demonstrated that high-dose therapy significantly decreased the risk of acne relapse, with no significant increase in adverse effects apart from retinoid dermatitis. While these results, with regards to relapse rates, are in accord with those found by other studies evaluating high-dose therapy, this study is the first to evaluate the efficacy and safety of such a treatment regimen. The non-significant difference in the rates of particularly concerning adverse effects (i.e. suicidal ideation, headaches, vision changes, etc) is reassuring to both prescribing clinicians and patients alike. However, it is nevertheless important to recognize limitations of this study including the absence of subject stratification according to acne severity, a factor that may influence response to therapy and risk of relapse, as well as the potential relapse and retrial events not captured by the short study follow-up period of 12 months.
Click to read the study in JAMA
Relevant Reading: The role of isotretinoin in acne therapy: why not as first-line therapy? facts and controversies
In-Depth [prospective, observational, intervention study]: This prospective, observational, intervention study enrolled 180 patients with severe nodular-cystic acne over a one year period. Patients were divided into one of two isotretinoin treatment groups, receiving either a cumulative dose of 220 mg/kg or more and or a cumulative dose of less than 220 mg/kg, and were subsequently monitored for either acne relapse (need for prescription acne medication or treatment) or retrial (need for an additional course of isotretinoin) for 12 months after the last oral istotretinoin dose. The relapse rate in the high-dose group was 26.9% (95%CI, 18.3%-37.8%) compared with 47.4% (95%CI, 32.3%-63%) in the low-dose group (P=.03). There was no significant difference in retrial rates between the two groups. Of the adverse effects measured, retinoid dermatitis was the only adverse effect that was significantly more common in the high-dose group (P=.02).
By Priyanka Vedak and Rif Rahman
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