Acne FDA Approved Aczone For Acne Treatment
Below is a MRR and PLR article in category Health Fitness -> subcategory Acne.
FDA Approval of Aczone for Acne Treatment
The U.S. Food and Drug Administration (FDA) has approved the marketing of Aczone (dapsone) Gel, 5%, for the topical treatment of acne vulgaris. However, individuals with the enzyme deficiency G6PD (Glucose 6-phosphate dehydrogenase) should be closely monitored through regular blood counts to check for susceptibility to hemolytic anemia.
Aczone: A New Solution
Aczone, developed by QLT USA Inc., is an aqueous gel containing 5% dapsone. Scientific studies have shown that incorporating dapsone into a Solvent Microparticulate (SMP) gel allows safe topical application. In two randomized, double-blind, vehicle-controlled clinical studies involving 3,000 acne patients, Aczone achieved a significant reduction in acne lesions and improved scores on the Global Acne Assessment Scale.
Clinical Findings and Safety
Common side effects observed during clinical trials included oiliness, peeling, dryness, and redness. However, these adverse effects were similar between patients treated with Aczone Gel and those given a placebo.
Among the approximately 3,500 participants in the Aczone clinical trial, 1.4% had G6PD deficiency, reflecting its prevalence in the North American population.
Ongoing Research and Future Plans
QLT is set to conduct a post-approval Phase IV study, monitoring 50 acne patients with G6PD deficiency over six months. Following this, QLT plans to submit an application to the FDA for a possible label update for Aczone.
Paul Hastings, President and CEO of QLT Inc., expressed enthusiasm about Aczone's approval, highlighting its importance in dermatology. "We are very pleased with the FDA's decision and confident in Aczone's potential as a new treatment option for acne patients," he stated.
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