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.
Agree to comply with study procedures and visit plan. Subject is capable of giving informed consent;
Male between the ages of 18 and 49 years, inclusive;
Clinically diagnosed as androgenetic alopecia;
Rating IIIv, IV and V on the Norwood Hamilton Scale; subject is willing to receive a ink dot tattoo;
Had a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA;
Had gray hair in the target alopecia area;
Had too short hair that, in the investogator's opinion, might affect hair growth assessment;
Had any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug (e.g., fungal or bacterial infection, severe seborrheic dermatitis, solar keratosis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy);
Parallel
KX-826 0.5% BID
Drug0.5% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
KX-826 1.0% BID
Drug1.0% of the investigational drug KX-826 to be applied topically to scalp twice daily for 24 weeks
Vehicle (Placebo) applied BID
DrugMatching placebo applied topically to scalp twice daily for 24 weeks
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.)
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.)
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
Target Area total hair counts
Target Area total hair counts change from baseline at week 6, 12, 18, and 24 in comparison to vehicle
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.)
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Suzhou Kintor Pharmaceutical Inc,
Lead sponsor
Suzhou Koshine Biomedica, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
