This study is a multicenter, randomized, double-blind, vehicle controlled, adaptive design phase 2/3 study to evaluate the efficacy and safety of topical KX-826 solution in Chinese male patients with androgenetic alopecia (AGA). It consisted of two phases, phase 2 dose exploration trial and phase 3 confirmatory trial.
In phase 2 study, around 90 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (30 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation. A Phase 2 statistical analysis will be performed when 90 patients complete the Week 24 visit or early withdrawal visit. Blood samples will be collected at the following time points: Day 1: 3 hours (pre-dose) W6 (Day 42): 3 hours (pre-dose) W12 (Day 84): 3 hours (pre-dose) In phase 3 study, around 666 adult male subjects with AGA (rating IIIv, IV and V on Hamilton-Norwood scale) were to be enrolled. All subjects would be evaluated with 1:1:1 randomized to receive KX-826 0.5% BID, KX-826 1.0% BID and vehicle in a double-blind fashion (222 subjects in each group), and would be treated for 24 weeks at the specified dose. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
756
0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
Matching placebo applied topically to scalp twice daily for 24 weeks
Peking University People's Hospital
Beijing, China
Target Area Non-vellus Hair count (TAHC) change from baseline at week 24 in comparison to vehicle.
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to vehicle (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: 24 weeks
Hair Growth Assessment (HGA)
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, 18 weeks and 24 weeks
Target Area Non-vellus Hair diameter (TAHW) assessment
Target Area Non-vellus Hair diameter (TAHW) change from baseline at week 6, 12, 18, and 24 in comparison to vehicle
Time frame: 6 weeks, 12 weeks, 18 weeks and 24 weeks
Target Area total hair counts
Target Area total hair counts change from baseline at week 6, 12, 18, and 24 in comparison to vehicle
Time frame: 6 weeks, 12 weeks, 18 weeks and 24 weeks
TAHC assessment
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to vehicle (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: 6 weeks, 12 weeks, 18 weeks
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