587 Efficacy and Safety of topical KX-826 in Male Subjects with Androgenetic Alopecia:A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study

(a)KX-826 is a novel AR antagonist. (b)Total 120 male AGA(Norwood-Hamilton type IIIv,IV,V) were enrolled, and randomized at ratio 1:1:1:1 to KX-826 2.5 mg BID group, 5 QD group placebo group. The primary endpoint was the mean change from baseline in target area non-vellus hair count(TAHC) week 24 comparison placebo. (c)The least square TAHC of 22.89 hairs/cm2, with significant increase 15.34 hairs/cm2 compared group(7.54 P=0.024). Sensitivity analysis efficacy showed consistent results. All groups had TAHW improvement 6,12,18,24 baseline, but no difference between groups. treatment numerically better HGA as QD/BID although did not reach statistical significance. incidence adverse drug reactions(ADR) 16.1%, pruritus(5.9%) most common ADR, followed by contact dermatitis(2.5%). No serious AE death occurred during study, led discontinuation. (d)For subjects AGA (Norwood-Hamilton classification IIIv,IV,V), well tolerated manageable 5mg significantly increased consistent. results will be further confirmed registration Phase III study.