The U.S. Food and Drug Administration (FDA) has approved Aczone (dapsone) Gel, 5%, for the topical treatment of acne vulgaris. However, patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency should be closely monitored with regular blood counts due to the risk of hemolytic anemia.
Aczone, a trademark of QLT USA Inc., is a topical gel containing 5% dapsone in an aqueous base. Research indicates that the Solvent Microparticulate (SMP) gel formulation allows for safe and effective topical application of dapsone. Clinical trials involving 3000 acne patients demonstrated a significant reduction in acne lesions and improved Global Acne Assessment Scores compared to a control group.
The most frequently reported side effects in clinical trials were oiliness, peeling, dryness, and erythema. Importantly, the incidence of these adverse events was similar between the Aczone Gel group and the control group.
Approximately 1.4% of the 3500 patients in the Aczone clinical trial program had G6PD deficiency, which aligns with the prevalence in the general North American population.
QLT will conduct a Phase IV study involving 50 acne patients with G6PD deficiency, monitoring them for six months. Following this study, QLT intends to submit an application to the FDA to re-evaluate Aczone’s labeling.
Paul Hastings, President and CEO of QLT Inc., stated that “Aczone represents a significant clinical advancement in dermatology, demonstrating both safety and efficacy in over 4,000 patients. We are very pleased with the FDA’s decision and confident in Aczone’s potential as a novel treatment for acne patients.”