Efficacy and safety of topical GT20029 in male patients with androgenetic alopecia: a multicenter, randomized, double-blind, placebo-controlled phase 2 study

Background Androgenetic alopecia (AGA) is a common, age-related, androgen-dependent condition. Dihydrotestosterone and androgen receptors play key roles in its pathogenesis.Methods This multicenter, randomized, double-blind, placebo-controlled Phase II trial evaluated the efficacy and safety of topical GT20029 in Chinese adult males with AGA. From April 2023 to April 2024, 180 eligible subjects (Hamilton-Norwood IIIv–V) were randomized equally into six groups receiving GT20029 (0.5% or 1.0%) or placebo, either once daily (QD) or twice weekly (BIW) for 12 weeks. The primary endpoint was the change in target area non-vellus hair count (TAHC) at Week 12; secondary endpoints included TAHC at Week 6, hair width (TAHW), and terminal/vellus hair ratio. Safety was assessed via adverse events (AEs).Results All four GT20029-treated groups showed significant increases in TAHC at Week 12 (p < 0.001), with 0.5% QD and 1.0% BIW groups showing significant improvement over their respective placebo groups (p = 0.032 and p = 0.023). TAHW also improved significantly in the 1.0% BIW group vs placebo (p = 0.011). TEAE incidence was similar across all groups and mostly mild.Conclusion Topical GT20029 demonstrated significant efficacy in hair regrowth with good tolerability. Further studies are warranted to confirm its therapeutic potential in AGA.