Efficacy and Safety of Dapsone Gel 5% for the Treatment of Acne Vulgaris in Adolescents

Two 12-week, randomized, vehicle-controlled, double-blinded pivotal studies and a 12-month, long-term, open-label, noncomparative safety study were conducted to evaluate the efficacy and safety of dapsone gel 5% in patients with acne vulgaris. Of 3516 participants enrolled in the 3 trials, 1306 participants (37%) were adolescents aged 12 to 15 years and comprised the subgroup reported here. Participants randomly were assigned to twice-daily treatment with dapsone gel (n=578) or vehicle gel (n=547) in the pivotal studies and received open-label treatment with dapsone gel in the long-term safety study (n=181). In the pivotal studies, success based on achieving a Global Acne Assessment Score (GAAS) of 0 (none) or 1 (minimal) at week 12 was significantly greater for the dapsone gel–treated adolescent participants (40.1%; 232/578) compared with the vehicle gel–treated adolescent participants (28.2%; 154/547)(P