Background: FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne.
Objective: Evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris.
Methods: Two identical phase 3 studies were conducted. Subjects were randomized 2:1 to once-daily FMX101 4% or foam vehicle for 12 weeks. The coprimary end points were the change in inflammatory lesion count from baseline and the rate of treatment success according to the Investigator's Global Assessment (a score of 0 or 1 for clear or almost clear, with a ≥2-grade improvement) at week 12.
Results: A total of 961 subjects were enrolled (study 04, N = 466; study 05, N = 495). Compared with vehicle, FMX101 4% demonstrated a significantly greater reduction in inflammatory lesions in both studies (P < .05) and a greater rate of treatment success in study 05 according to the Investigator's Global Assessment (P < .05). Pooled analyses of the 2 studies demonstrated statistical significance for both coprimary end points (all P < .05). Noninflammatory lesion count was also significantly reduced with FMX101 4% versus with vehicle in both studies. FMX101 4% was generally safe and well tolerated. Skin-related adverse events were reported in less than 1% of subjects treated with FMX101 4%.
Limitations: Longer-term efficacy and safety outcomes are needed (ongoing).
Conclusion: FMX101 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved Investigator's Global Assessment scores in patients with moderate-to-severe acne.
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Article Synopsis
- - FMX101 4% is a topical foam formulation of minocycline approved for treating moderate-to-severe acne vulgaris, and a study was conducted to evaluate its effectiveness and safety among Chinese patients.
- - In a phase 3 trial involving 372 subjects, results showed that FMX101 4% led to a significant reduction in inflammation lesion count (ILC) and noninflammatory lesion count (nILC), along with a higher treatment success rate compared to a control foam after 12 weeks.
- - The treatment was generally safe and well-tolerated, with mostly mild-to-moderate side effects and no serious adverse events linked to the treatment.
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