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FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne.
A recent study published in Journal of the American Academy of Dermatology evaluated the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris.
The present study entailed two identical double-blinded, phase-3 clinical trials. Subjects were randomized 2:1 – to once-daily FMX101 4% or foam vehicle for 12 weeks. The co-primary end points were the change in inflammatory lesion count from baseline and the rate of treatment success, according to the Investigators Global Assessment (a score of 0 or 1 for clear or almost clear, with a ≥2-grade improvement), at week-12.
Overall, 961 subjects were enrolled (study 04, N = 466; study 05, N = 495). The findings revealed that compared to vehicle, FMX101 4% demonstrated a significantly greater reduction in inflammatory lesions in both studies and a greater rate of treatment success in the study 05, according to the Investigators Global Assessment. Pooled analyses of the two studies demonstrated statistical significance for both coprimary end points. Non-inflammatory lesion count was also significantly reduced with FMX101 4% versus with vehicle, in both studies. Moreover, FMX101 4% was generally safe and well tolerated. Skin-related adverse events were reported in less than 1% of subjects treated with FMX101 4%.
Therefore, it was concluded that FMX101 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved Investigators Global Assessment scores in patients with moderate-to-severe acne.
Source: Journal of the American Academy of Dermatology. 2019 Jan;80(1):168-177. doi: 10.1016/j.jaad.2018.08.020.