Randomized controlled trial on the efficacy and safety of the combination therapy of topical 0.1% finasteride − 5% Minoxidil in male androgenetic alopecia

• Published in: Archives of dermatological research Vol. 317; no. 1; p. 691
• Main Authors: Lubis, Farah Faulin, Legiawati, Lili, Saulina, Martha, Saldi, Siti R.F.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 10.04.2025; Springer Nature B.V
• Subjects: 5-alpha Reductase Inhibitors - administration & dosage; 5-alpha Reductase Inhibitors - adverse effects; Administration, Cutaneous; Administration, Topical; Adult; Alopecia; Alopecia - diagnosis; Alopecia - drug therapy; Baldness; Clinical trials; Contact dermatitis; Dermatology; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - methods; Erectile dysfunction; Finasteride - administration & dosage; Finasteride - adverse effects; Hair; Hair - drug effects; Hair - growth & development; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Minoxidil; Minoxidil - administration & dosage; Minoxidil - adverse effects; Original Paper; Side effects; Treatment Outcome; Young Adult; Topical; Finasteride; Minoxidil; Androgenetic alopecia; Side effect
• ISSN: 1432-069X; 0340-3696; 1432-069X
• 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.