Tooraj Joseph Raoof1, Deirdre Hooper2, Angela Moore3, Martin Zaiac4, Tory Sullivan5, Leon Kircik6, Edward Lain7, Jasmina Jankicevic8, Iain Stuart9. 1. T. Joseph Raoof MD Inc/Encino Research Center, Encino, CA. 2. Delricht Research, New Orleans, LA. 3. Arlington Research Center, Arlington, TX; Baylor University Medical Center, Dallas, TX. 4. Department of Dermatology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL; Greater Miami Skin and Laser Center, Miami Beach, FL. 5. Sullivan Dermatology, North Miami Beach, FL. 6. Icahn School of Medicine at Mount Sinai, New York, NY. 7. Austin Institute for Clinical Research, Austin, TX. 8. Foamix Pharmaceuticals, Inc., Bridgewater, NJ. 9. Foamix Pharmaceuticals, Inc., Bridgewater, NJ. Electronic address: iain.stuart@foamix.com.
Abstract
BACKGROUND:FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV). OBJECTIVE: To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris. METHODS: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement). RESULTS: There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated. LIMITATIONS: The efficacy and safety of FMX101 4% were not characterized in participants with mild AV. CONCLUSION:FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.
RCT Entities:
BACKGROUND: FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV). OBJECTIVE: To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris. METHODS: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement). RESULTS: There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated. LIMITATIONS: The efficacy and safety of FMX101 4% were not characterized in participants with mild AV. CONCLUSION: FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.