{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T20:37:45Z","timestamp":1777581465227,"version":"3.51.4"},"reference-count":26,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T00:00:00Z","timestamp":1719792000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>FMX101 4%, as a topical foam formulation of minocycline, has been approved by US Food and Drug Administration for the treatment of moderate\u2010to\u2010severe acne vulgaris (AV).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of FMX101 4% in treating Chinese subjects with moderate\u2010to\u2010severe facial AV.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a multi\u2010centre, randomized, double\u2010blind, vehicle\u2010controlled phase 3 study in Chinese subjects with moderate\u2010to\u2010severe AV. Eligible subjects were randomized 2:1 to receive either FMX101 4% or vehicle foam treatment for 12\u2009weeks. 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 372 subjects were randomized into two groups (FMX101 4% group, <jats:italic>n<\/jats:italic>\u2009=\u2009248; vehicle group, <jats:italic>n<\/jats:italic>\u2009=\u2009124). After 12\u2009weeks treatment, the reduction in ILC from baseline was statistically significant in favour of FMX101 4%, compared with vehicle foam (\u221221.0 [0.08] vs. \u221212.3 [1.14]; LSM [SE] difference, \u22128.7 [1.34]; 95% CI [\u221211.3, \u22126.0]; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). 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 (\u221219.4 [1.03] vs. \u221214.9 [1.47]; LSM [SE] difference, \u22124.5 [1.74]; 95% CI [\u22128.0, \u22121.1]; <jats:italic>p<\/jats:italic>\u2009=\u20090.009). Most treatment\u2010emergent adverse events (TEAEs) were mild\u2010to\u2010moderate in severity, and no treatment\u2010related treatment\u2010emergent serious adverse event (TESAE) occurred. Thus, FMX101 4% was considered to be a safe and well\u2010tolerated product during the 12\u2010week treatment period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>FMX101 4% treatment for 12\u2009weeks could lead to significantly reduced ILC and nILC, and improved IGA treatment success rate in Chinese subjects with moderate\u2010to\u2010severe facial AV. It also showed a well acceptable safe and tolerability profile.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.20159","type":"journal-article","created":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T10:02:01Z","timestamp":1719828121000},"page":"967-975","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy and safety of topical minocycline foam (FMX101 4%) in treatment of Chinese subjects with moderate\u2010to\u2010severe facial acne vulgaris: A phase 3, multi\u2010centre, randomized, double\u2010blind, vehicle\u2010controlled study"],"prefix":"10.1111","volume":"39","author":[{"given":"Yan","family":"Le","sequence":"first","affiliation":[{"name":"Department of Dermatology, Huashan Hospital Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenlin","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatology The Second Affiliated 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Dermatology, Huashan Hospital Fudan University  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qing","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Dermatology Qilu Hospital of Shandong University  Jinan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huiping","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology Tianjin Medical University General Hospital  Tianjin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mingye","family":"Bi","sequence":"additional","affiliation":[{"name":"Department of Medical Cosmetology Wuxi People's Hospital  Wuxi China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haiying","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology Peking University Shougang Hospital  Beijing 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