Lubis Farah Faulin, Legiawati Lili, Saulina Martha, Saldi Siti R F
Department of Dermatology and Venereology Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia.
Department of Dermatology and Venereology Faculty of Medicine, Universitas Indonesia - Tangerang District General Hospital, Tangerang, Indonesia.
Arch Dermatol Res. 2025 Apr 10;317(1):691. doi: 10.1007/s00403-025-04216-9.
Current FDA-approved treatments for androgenetic alopecia (AGA) are oral finasteride and topical minoxidil. Topical finasteride offers a potential alternative with similar efficacy and fewer systemic side effects. This study evaluated the effectiveness and safety of combining topical finasteride and minoxidil for male AGA. This 12-week randomized controlled trial divided subjects into two groups which are topical finasteride 0.1%-minoxidil 5% (treatment) and topical minoxidil 5% (control) (NCT05990400, registered 2023-08-04). Hair density, hair diameter, terminal hair rate, and vellus hair rate (assessed using phototrichogram), and the occurrence of side effects (SE) was monitored at four-week intervals. Out of 40 subjects, 2 dropped out in the treatment group. Significant increases in hair density, diameter, and terminal hair rate; and decrease of vellus hair rate were observed at each visit compared to baseline, yet no differences between groups. Systemic SEs included libido reduction (control), mild erectile dysfunction, and chest pain (treatment). Common local SEs (itching, shedding, and dandruff) were similar between groups. One patient (treatment) experienced contact dermatitis. Combining topical finasteride 0.1% with topical minoxidil 5% has similar safety and effectiveness for increasing hair density and diameter in male AGA patients compared to topical minoxidil 5% after 12 weeks of observation.
美国食品药品监督管理局（FDA）目前批准用于治疗雄激素性脱发（AGA）的药物是口服非那雄胺和外用米诺地尔。外用非那雄胺提供了一种潜在的替代方案，疗效相似且全身副作用较少。本研究评估了外用非那雄胺和米诺地尔联合治疗男性AGA的有效性和安全性。这项为期12周的随机对照试验将受试者分为两组，即外用0.1%非那雄胺-5%米诺地尔组（治疗组）和外用5%米诺地尔组（对照组）（NCT05990400，于2023年8月4日注册）。每隔四周监测一次头发密度、头发直径、终毛率和毳毛率（使用毛发显微镜评估）以及副作用（SE）的发生情况。40名受试者中，治疗组有2人退出。与基线相比，每次随访时均观察到头发密度、直径和终毛率显著增加，毳毛率降低，但两组之间无差异。全身副作用包括性欲减退（对照组）、轻度勃起功能障碍和胸痛（治疗组）。两组常见的局部副作用（瘙痒、脱屑和头皮屑）相似。一名患者（治疗组）出现接触性皮炎。观察12周后，与外用5%米诺地尔相比，外用0.1%非那雄胺与5%米诺地尔联合使用在增加男性AGA患者头发密度和直径方面具有相似的安全性和有效性。
