Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment.

Author(s): Lucky AW, Maloney JM, Roberts J, Taylor S, Jones T, Ling M, Garrett S, Dapsone Gel Long-Term Safety Study Group

Affiliation(s): Dermatology Research Associates Inc., Cincinnati, OH 45230, USA. dermresearch@fuse.net

Publication date & source: 2007-10, J Drugs Dermatol., 6(10):981-7.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Dapsone gel 5%, a topical formulation of dapsone, was shown to deliver clinically effective doses of dapsone with minimal systemic absorption in 2 randomized, vehicle-controlled, 12-week studies of patients with acne vulgaris. A 12-month, open-label, long-term safety study further evaluated the safety and efficacy of dapsone gel. Patients at least 12 years of age with acne vulgaris (N = 486) applied dapsone gel twice daily for up to 12 months. Application site reactions related to treatment were reported in 8.2% of the patients and were mostly mild to moderate in severity. Common nonapplication site adverse events included headache (20%) and nasopharyngitis (15%). No significant changes in hematology or blood chemistry parameters were observed. At one month, mean reduction from baseline in inflammatory lesion counts was 30.6%. At 12 months, mean reduction from baseline was 58.2%, 19.5%, and 49.0% for inflammatory, noninflammatory, and total lesion counts, respectively, (all P=.002 compared to baseline). These results show that dapsone gel 5% is safe and effective for long-term treatment of acne vulgaris and has a rapid onset of action.