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Article
April 2, 1982

Synthetic vitamin A analogue (isotretinoin) awaiting approval for cystic acne therapy

JAMA. 1982;247(13):1800-1802. doi:10.1001/jama.1982.03320380006003

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Abstract

An oral synthetic retinoid, which according to some dermatologists will revolutionize treatment for severe cystic acne, is likely to be available for general clinical use later this year.

Isotretinoin 13-cis-retinoic acid) has been recommended for approval by the Food and Drug Administration pending some labeling changes by its manufacturer, Hoffman-La Roche Inc, Nutley, NJ.

About one third of the university dermatology centers in the United States have conducted clinical trials with one of several synthetic retinoids, and isotretinoin appears to be the most effective for treating cystic acne, according to Carl Ehmann, MD, director of clinical research for dermatology at Hoffman-La Roche.

Isotretinoin has an impressive track record so far: At doses ranging from 0.02 to 2.0 mg/kg/day, dermatologists from the United States and several European countries report that virtually all patients experience complete amelioration of their acne, usually after an eight- to 16-week course of treatment. In

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