Efficacy and safety of topical finasteride spray solution in the treatment of Chinese men with androgenetic alopecia: A phase III, multicenter, randomized, double-blind, placebo-controlled study

Abstract Background: Topical finasteride is a novel treatment for men with an androgenetic alopecia (AGA). This study aimed to evaluate the efficacy and safety of topical finasteride spray solution in Chinese men with AGA. Methods: This randomized, double-blind, placebo-controlled, phase III trial enrolled 270 individuals with AGA from 16 sites across China between December 2021 and March 2023. The participants were randomized at a ratio of 2:1 to receive either topical finasteride or placebo treatment once daily for 24 weeks. The primary endpoint was the change from baseline in target area (0.903 cm 2 area) hair count at week 24. The secondary endpoints were change from baseline in target area hair count at week 12, target area terminal hair count at weeks 12 and 24, target area terminal hair width at week 24, and target area hair width at week 24; an improvement of vertex hair growth assessed by the investigator at week 24; and the patient-assessed scores on the Male Hair Growth Questionnaire at week 24. Results: A total of 270 individuals were enrolled and randomized and 251 completed the study. Compared with the placebo group, in the topical finasteride group, the change from baseline in target area hair count was significantly higher at week 24 ( P <0.05), although it was only numerically higher at week 12 ( P = 0.0688). Significant differences favoring topical finasteride over placebo were observed for change from baseline in target area terminal hair count at weeks 12 ( P <0.05) and 24 ( P <0.01). The improvement of vertex hair growth assessed by the investigator was significantly greater in the topical finasteride group vs. the placebo group at week 24 ( P <0.01). Topical finasteride was generally safe and well-tolerated. Conclusions: In Chinese men with AGA, topical finasteride spray solution increased hair growth and showed good safety and tolerability profile during a 24-week treatment period. Clinical Trial Registration: Clinicaltrials.gov identifier: NCT05135468.