LAUSR

Introduction Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution—test product (TP)—compared with 5% minoxidil alcohol-based topical solutions—reference product 1 (RP1) and reference product 2 (RP2)—in Indian men with androgenetic alopecia. Methods In this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp. Results All screened patients ( N  = 100) were enrolled and randomized to TP ( n  = 33), RP1 ( n  = 33), or RP2 ( n  = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] ( p -value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], ( p -value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups. Conclusions Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations. Trial Registration Clinical Trial Registry of India; CTRI/2018/11/016431.