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

• Published in: Journal of drugs in dermatology Vol. 6; no. 10; p. 981
• Main Authors: Lucky, Anne W, Maloney, J Michael, Roberts, Janet, Taylor, Susan, Jones, Terry, Ling, Mark, Garrett, Steven
• Format: Journal Article
• Language: English
• Published: United States 01.10.2007
• Subjects: Acne Vulgaris - blood; Acne Vulgaris - drug therapy; Acne Vulgaris - pathology; Adolescent; Adult; Aged; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Anti-Infective Agents - blood; Child; Dapsone - administration & dosage; Dapsone - adverse effects; Dapsone - blood; Female; Gels; Humans; Male; Middle Aged; Treatment Outcome
• ISSN: 1545-9616

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.