Comparison of a New 5% Minoxidil Foam and Rogaine^? in the Treatment of Androgenetic Alopecia in Chinese Men: A Randomized, Double-Blind, Phase III, Equivalence Trial

Androgenetic alopecia (AGA) is a common cause of hair loss in adults. We aimed to compare the e5cacy and safety of topical generic 5% new minoxidil foam (NMF) versus 5% minoxidil Rogaine((R)) foam in male patients with AGA. A randomized, doubleblind, controlled, phase III, equivalence trial in 10 centers in China between December 25, 2019, and June 28, 2021, was performed. In total, 417 men patients (>= 18 years) with AGA were randomized to receive 5% NMF (211 patients) or 5% Rogaine((R)) foam (206 patients) 1 g two times daily for 24 weeks.,eprimary outcome was the changes in nonvellus target area hair counts (TAHC) from baseline to week 24. Equivalence was concluded if the 95% conCdence interval (CI) for the treatment diDerence between the 5% NMF and Rogaine((R)) groups was within (-8.00, 8.00). After 24 weeks of treatment, the mean diDerence in the change of nonvellus TAHC between the 5% NMF group and the Rogaine((R)) group was -3.85 +/- 1.62 hair/cm(2) in full-analysis set (FAS) and -3.96 +/- 1.68 hair/cm(2) in per-protocol set (PPS), and the 95% CI of mean diDerence was (-7.03, -0.67) in FAS and (-7.26, -0.66) in PPS. No signiCcant diDerences were found between the two groups in hair diameter, the ratio of terminal hair to vellus hair, the global photographic assessment by investigators, and adverse events (all P > 0.05). 5% NMF is as eDective as Rogaine((R)) in increasing hair density and hair diameter in AGA patients and was found to be safe.,is trial is registered with CTR20191708.