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# FDA OKs New Allergan Acne Treatment
- URL: https://www.fdaweb.com/fda-oks-new-allergan-acne-treatment/
- Published: 2016-02-26T12:00:00.000Z
- Updated: 2026-09-15T02:39:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134891

FDA has approved Allergan’s Aczone (dapsone) gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. According to the company, the gel treats both inflammatory and non-inflammatory acne in a once-a-day application with a new pump delivery system. Allergan says 4,340 acne patients were studied in two identically designed 12-week trials in which Aczone’s safety and efficacy were assessed. FDA approved the product based on co-primary endpoints of the Global Acne Assessment Score and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline), the company says. Allergan reports study results at week 12 showed that inflammatory lesions were reduced by 15.8 lesions vs 13.9 lesions with vehicle and non-inflammatory lesions were reduced by 20.7 lesions vs 18.0 lesions with vehicle (39.4%). It adds that out of 2161 patients who used Aczone Gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle and 0.9% experienced pruritus vs 0.5% with vehicle.