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);
Suzhou Kintor Pharmaceutical Inc,
Lead sponsor
Suzhou Koshine Biomedica, Inc.
Collaborator