Dapsone Gel 5% for the Treatment of Acne Vulgaris: Safety and Efficacy of Long-Term (1 Year) Treatment
October 2007 | Volume 6 | Issue 10 | Original Article | 981 | Copyright © October 2007
Anne W. Lucky MD, J. Michael Maloney MD, Janet Roberts MD, Susan Taylor MD, Terry Jones MD, Mark Ling MD PhD, Steven Garrett DDS, for the Dapsone Gel Long-Term Safety Study Group
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.