This was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 Tincture in Chinese adult female subjects with AGA.
KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of female pattern hair loss (androgenetic alopecia). A total of 160 female subjects were randomized to one of four cohorts: 2.5 mg QD, 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks. The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC (Target Area Hair Counts)at Week 24 in comparison to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
2.5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks
2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
China-Japan Friendship Hospital
Assessment of change in Target Area Hair Counts
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to placebo (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
Assessment of change in Hair Growth Assessment score
Changes from baseline in 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: 6,12,18 and 24 weeks
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5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks
Placebo applied topically to scalp once daily for 24 weeks
Placebo applied topically to scalp twice daily for 24 weeks
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Xiangya Hospital Central South University
Changsha, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
...and 5 more locations