Le Yan, Yang Wenlin, Lu Jianyun, Jiang Xian, Guo Qing, Huang Chunyun, Sun Qing, Wang Huiping, Bi Mingye, Wang Haiying, Geng Songmei, Yang Bin, Xu Ai-E, Cui Yong, Man Xiaoyong, Zhao Yi, Zhang Litao, Li Linfeng, Song Zhiqiang, Chen Jin, Cheng Hao, Zhu Wei, Han Xiuping, Li Shanshan, Lin Tong, Zhang Chunlei, Li Jiuhong, Li Yanling, Ding Yangfeng, Wang Linda, Zhu Yuefang, Xiang Leihong
Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.
Department of Dermatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
J Eur Acad Dermatol Venereol. 2025 May;39(5):967-975. doi: 10.1111/jdv.20159. Epub 2024 Jul 1.
FMX101 4%, as a topical foam formulation of minocycline, has been approved by US Food and Drug Administration for the treatment of moderate-to-severe acne vulgaris (AV).
To evaluate the efficacy and safety of FMX101 4% in treating Chinese subjects with moderate-to-severe facial AV.
This was a multi-centre, randomized, double-blind, vehicle-controlled phase 3 study in Chinese subjects with moderate-to-severe AV. Eligible subjects were randomized 2:1 to receive either FMX101 4% or vehicle foam treatment for 12 weeks. The primary efficacy endpoint was the change in inflammation lesion count (ILC) from baseline at week 12. The key secondary endpoint was the treatment success rate according to Investigator's Global Assessment (IGA) at week 12.
In total, 372 subjects were randomized into two groups (FMX101 4% group, n = 248; vehicle group, n = 124). After 12 weeks treatment, the reduction in ILC from baseline was statistically significant in favour of FMX101 4%, compared with vehicle foam (-21.0 [0.08] vs. -12.3 [1.14]; LSM [SE] difference, -8.7 [1.34]; 95% CI [-11.3, -6.0]; p < 0.001). FMX101 4% treatment yielded significantly higher IGA treatment success rate at week 12 as compared to the control treatment (8.06% vs. 0%). Applying FMX101 4% also resulted in significant reduction in noninflammatory lesion count (nILC) versus vehicle foam at week 12 (-19.4 [1.03] vs. -14.9 [1.47]; LSM [SE] difference, -4.5 [1.74]; 95% CI [-8.0, -1.1]; p = 0.009). Most treatment-emergent adverse events (TEAEs) were mild-to-moderate in severity, and no treatment-related treatment-emergent serious adverse event (TESAE) occurred. Thus, FMX101 4% was considered to be a safe and well-tolerated product during the 12-week treatment period.
FMX101 4% treatment for 12 weeks could lead to significantly reduced ILC and nILC, and improved IGA treatment success rate in Chinese subjects with moderate-to-severe facial AV. It also showed a well acceptable safe and tolerability profile.
4%的FMX101作为米诺环素的一种局部泡沫制剂，已获美国食品药品监督管理局批准用于治疗中度至重度寻常痤疮（AV）。
评估4%的FMX101治疗中度至重度面部AV中国患者的疗效和安全性。
这是一项针对中度至重度AV中国患者的多中心、随机、双盲、赋形剂对照的3期研究。符合条件的受试者按2:1随机分组，接受4%的FMX101或赋形剂泡沫治疗12周。主要疗效终点是第12周时炎症性皮损计数（ILC）较基线的变化。关键次要终点是根据研究者整体评估（IGA）在第12周时的治疗成功率。
总共372名受试者被随机分为两组（4%的FMX101组，n = 248；赋形剂组，n = 124）。治疗12周后，与赋形剂泡沫相比，4%的FMX101组ILC较基线的降低具有统计学意义（-21.0 [0.08] 对比 -12.3 [1.14]；最小二乘均值 [标准误] 差异，-8.7 [1.34]；95% 置信区间 [-11.3, -6.0]；p < 0.001）。与对照治疗相比，4%的FMX101治疗在第12周时IGA治疗成功率显著更高（8.06% 对比 0%）。在第12周时，应用4%的FMX101与赋形剂泡沫相比，非炎症性皮损计数（nILC）也显著降低（-19.4 [1.03] 对比 -14.9 [1.47]；最小二乘均值 [标准误] 差异，-4.5 [1.74]；95% 置信区间 [-8.0, -1.1]；p = 0.009）。大多数治疗中出现的不良事件（TEAE）严重程度为轻度至中度，未发生与治疗相关的治疗中出现的严重不良事件（TESAE）。因此，在12周的治疗期内，4%的FMX101被认为是一种安全且耐受性良好的产品。
4%的FMX101治疗12周可使中度至重度面部AV中国患者的ILC和nILC显著降低，并提高IGA治疗成功率。它还显示出可接受的安全性和耐受性。
