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.

中文翻译：

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新型局部用米诺环素泡沫治疗中度至重度寻常痤疮的疗效和安全性：一项3期研究。

背景技术FMX101 4％的局部米诺环素泡沫已被证明是治疗寻常痤疮（AV）的有效且安全的方法。目的进一步评估4％FMX101治疗中度至重度痤疮的疗效和安全性。方法进行了为期12周的多中心，随机（1：1），双盲，车辆对照研究。共同的主要终点是炎症损害计数相对于基线的绝对变化和治疗成功率（研究者的整体评估评分为0或1，且≥2级改善）。结果意向性治疗人群共有1488名参与者。根据研究者的总体评估，FMX101 4％组与基线相比，炎性病变的数量明显减少（P <.0001），并且治疗成功率更高（P <。与第12周的泡沫媒剂组相比，该指数为0001），而FMX101 4％通常是安全且耐受性良好的。局限性在轻度AV患者中，FMX101 4％的功效和安全性未得到表征。结论FMX101 4％的米诺环素外用泡沫治疗中重度AV是安全有效的。