J Dermatolog Treat. 2025 Dec;36(1):2574304. doi: 10.1080/09546634.2025.2574304. Epub 2025 Dec 2.
ABSTRACT
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.
PMID:41328006 | DOI:10.1080/09546634.2025.2574304
