The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution.
GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of androgenetic alopecia. A total of 180 adult male subjects with androgenetic alopecia (AGA) (according to Hamilton-Norwood classification IIIv, IV and V) were enrolled in this study. All subjects were randomly assigned in a 1:1:1:1:1:1ratio to investigational drug groups A, B, C and D and placebo groups E and F (i.e., 30 subjects in each group) and treated for 12 weeks at the specified dose and frequency for each group. The primary endpoint of the study is to evaluate the efficacy and safety of GT20029 solution in the treatment of androgenetic alopecia (AGA) in Chinese adult males and to determine the recommended dose for phase III trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
5mg (0.5%) and 10mg (1%) one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period
5mg (0.5%) and 10mg (1%) matching placebo one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) matching placebo twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period
Dermatology department, Huashan Hospital, Fudan University
Shanghai, China
Change in non-vellus hair count (TAHC, Target Area Hair Counts) within target area (change from baseline at 12 weeks of treatment)
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)
Time frame: 12 weeks
Hair growth (HGA) assessment, including subject self-assessment and investigator assessment (change from baseline at 6 and 12 weeks of treatment)
Changes from baseline HGA (Hair Growth Assessment) score by Principal Investigator and subjects (HGA scale ranged from -3 to 3 and represented decreases from baseline that were substantial, moderate, slight, no change, slight increases, moderate increases, and substantial increases, respectively. HGA improvement was defined as a hair growth assessment score of larger than 0.)
Time frame: 6 weeks, 12 weeks
TAHC assessment
Change in non-vellus hair count (TAHC) in the target area (change from baseline at 6 weeks of treatment)
Time frame: 6 weeks
TAHW assessment
Change in non-vellus hair diameter (TAHW) in the target area (change from baseline at 6 and 12 weeks of treatment)
Time frame: 6 weeks, 12 weeks
Terminal hair/vellus hair ratio assessment
Change in terminal hair/vellus hair ratio (change from baseline at 6 and 12 weeks of treatment).
Time frame: 6 weeks, 12 weeks
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