Efficacy and safety of topical dapsone gel 7.5% for treatment of acne vulgaris by fitzpatrick skin type



Introduction: We evaluated safety and efficacy of dapsone gel 7.5% (DAP) in acne patients by Fitzpatrick skin type.
Methods: Data were pooled from 2 identically designed, phase 3, multicenter, randomized, double-blind studies in patients ≥12 years of age with moderate acne. Patients applied DAP or vehicle (VEH) once daily for 12 weeks. Efficacy assessments included Global Acne Assessment Score (GAAS) and lesion counts. Patients self-evaluated acne impact using Acne Symptom and Impact Scale (ASIS). Adverse events (AEs) and dermal tolerability were assessed.
Results: In total, 4327 patients (2216 type I–III, 2111 type IV–VI) were included. At week 12, mean GAAS change from baseline was significantly greater with DAP versus VEH in skin types I–III and IV–VI (both, P<0.001). Additionally, 71.4% with types I–III and 76.6% with types IV–VI using DAP achieved ≥1-grade improvement in GAAS at week 12 versus 62.8% and 67.9% using VEH (P<0.001). In types I–III and IV–VI, mean week 12 percent reductions were significantly greater for DAP versus VEH in inflammatory lesions (types I–III, P<0.001; IV–VI, P=0.002), comedones (types I–III, P<0.001; IV–VI, P=0.01), and total lesions (both, P<0.001). For both skin type groups, inflammatory lesion improvements occurred first; similar improvement patterns occurred in GAAS, comedones, and ASIS domains. Local dermal tolerability and AE incidences were similar between skin type groups and between DAP and VEH.
Conclusion: Once-daily DAP monotherapy was safe and effective in lighter and darker Fitzpatrick skin type patients with moderate acne.


Dr. Susan Taylor