FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).
To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.
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).
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.
The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.
FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.Le texte complet de cet article est disponible en PDF.
Key words : acne vulgaris, clinical study, efficacy, foam, minocycline, randomized, safety, topical administration
Abbreviations used : AV, CI, CK, IGA, LSM, TEAE, AE, ITT
| Funding sources: Sponsored by Foamix Pharmaceuticals, Inc.
| Disclosure: Drs Raoof, Hooper, Zaiac, Sullivan, Lain, and Moore served as investigators for Foamix Pharmaceuticals. Dr Kircik is an investigator and consultant for Foamix Pharmaceuticals. Dr Jankicevic is a consultant for Foamix Pharmaceuticals. Dr Stuart is an employee and stockholder at Foamix Pharmaceuticals.