Acne therapy with isotretinoin in dermatologic practice. A multicenter phase IV study of 788 patients

: In a multicenter study, 788 patients suffering from severe acne resistant to therapy were treated with isotretinoin by 758 dermatologists in private practices. The study was conducted using standardized test forms and questionnaires. The goal of the study was to establish the risk/benefit ratio of the drug, if it was applied to patients of a dermatological practice. The initial daily dose amounted to 0.5 mg/kg body weight, the time of treatment was 12 to 16 weeks. The clinical efficacy was judged very good or good by 90% of the doctors and patients. The kind, frequency, and intensity of the side effects observed corresponded with those found in previous studies conducted at hospitals. Our critical analysis of the results left no doubt about the therapeutic value and the safety of isotretinoin, if it is used by dermatologists in private practices.