Efficacy and Safety of Topical KX-826 in Male Subjects with Androgenetic Alopecia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study

The study involved 120 male subjects with Androgenetic Alopecia (AGA) who were divided into four groups: KX-826 2.5 mg BID group, KX-826 5 mg QD group, KX-826 5 mg BID group, and a placebo group. The primary endpoint was the mean change from baseline in target area non-vellus hair count (TAHC) at week 24. The KX-826 5 mg BID group showed a significant increase of 15.34 hairs/cm2 compared to the placebo group (P=0.024). All KX-826 treatment groups showed better hair growth area (HGA) improvement compared to the placebo group, although the difference was not statistically significant. The most common adverse drug reaction was pruritus (5.9%), followed by contact dermatitis (2.5%). No serious adverse events or deaths occurred during the study, and no adverse events led to treatment discontinuation. The study concluded that KX-826 was well tolerated and significantly increased TAHC in male subjects with AGA.