A Randomized, Double-Blind, Placebo and Active Controlled Phase II Study to Evaluate the Safety and Efficacy of Novel Dutasteride Topical Solution (0.01%, 0.02%, and 0.05% w/v) in Male Subjects With Androgenetic Alopecia

This Phase II study assessed the safety and efficacy of a novel dutasteride topical solution in 135 male subjects with androgenetic alopecia (AGA) across six centers in India. The study found that the 0.05% dutasteride topical solution significantly increased target area hair count (TAHC) at the vertex after 24 weeks compared to placebo and was comparable to oral finasteride, with minimal systemic side effects. The 0.05% solution also outperformed oral finasteride in increasing TAHC and hair width, with no significant adverse events reported. Investigator assessments and patient satisfaction scores supported the efficacy of the 0.05% solution, indicating enhanced hair growth and higher satisfaction. The study concludes that the 0.05% dutasteride topical solution is a promising alternative for AGA treatment, offering effective hair regrowth with fewer side effects than oral formulations, though further large-scale Phase III trials are needed.