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Once-daily dapsone Gel, 7.5% (Aczone, Allergan PlC), a new prescription topical treatment for inflammatory and non-inflammatory acne in patients 12 years of age and older, received FDA approval. It will be available it May 2016.
In clinical trials of dapzone gel, 7.5%, safety and efficacy were assessed in 2 identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies. A total of 4,340 acne patients were randomized to receive either dapzone Gel, 7.5% (n=2162) or vehicle (n=2178). The majority of patients (99%; n=4339) had moderate acne, with a baseline score of 3 on the Global Acne Assessment Score (GAAS). Dapzone gel, 7.5% was approved based on co-primary endpoints of the GAAS and lesion counts (20 to 50 inflammatory and 30 to 100 non-inflammatory lesions at baseline).
At week 12, inflammatory lesions were reduced by 15.8 lesions (54.6%; n=2162) vs 13.9 lesions with vehicle (48.1%; n=2178), and non-inflammatory lesions were reduced by 20.7 lesions (45.1%) vs 18.0 lesions with vehicle (39.4%). The GAAS success rate in patients was 29.8% (n=2162) vs 21.1% with vehicle (n=2178). In addition to efficacy, dapzone gel, 7.5% has a proven tolerability profile. Out of 2161 patients who used dapzone gel, 7.5%, 1.1% experienced mild application-site dryness vs 1.0% with vehicle (n=2175), and 0.9% experienced pruritus vs 0.5% with vehicle.
“Aczone Gel, 7.5%, is a new once-daily option that was shown to have significant improvement in patients’ acne after 12 weeks of use,” said Linda Stein Gold, MD, director of dermatology clinical research, division head of dermatology at Henry Ford Health System in Michigan and a lead investigator in the studies. “This new formulation was well-tolerated, which is especially important to many of my female patients.”