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| Name | Class |
|---|---|
| Suzhou Koshine Biomedica, Inc. | INDUSTRY |
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This is a phase III, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of KX-826 for topical use in Chinese adult male patients with androgenetic alopecia (AGA).
In this study, around 740 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 randomized to receive active drug or placebo in a double-blind fashion (370 subjects in each group), and would be treated for 24 weeks at the specified dose and frequency of each group. During the study, the subjects would undergo periodic efficacy and safety-related examinations and evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KX-826-0.5% BID | Experimental | treatment dose group of 0.5% BID(0.5%) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KX-826-(5%) BID | Drug | Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized active drug would be administered to the scalp once in the morning and once in the evening. |
| Measure | Description | Time Frame |
|---|---|---|
| change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo). | change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo). | mean change from baseline after 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure: | Hair growth assessment (HGA) of patient self-assessment, and Hair growth assessment (HGA) of investigator assessment | change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method |
| Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
Male, aged ≥ 18 years, in good general health;
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| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang | Peking University People's Hospital | Principal Investigator |
| Qinping Yang | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital Of Anhui Medical University | Hefei | Anhui | China | |||
| Beijing Friendship Hospital,Capital Medical University |
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|
|
| Placebo | Other | Dosage and administration: Topical application, 7 sprays (approximately 1 ml)/time, in the target area of the scalp, starting from the center of the affected area and massaging with hands until absorption. It should be used when the hair and scalp are completely dry. Wash hands after use. The randomized matching placebo would be administered to the scalp once in the morning and once in the evening. |
|
Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment) |
| change from baseline after 6, 12, 18, and 24 weeks of treatment |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Tongren Hospital,Cmu | Beijing | Beijing Municipality | China |
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China |
| Peking University First Hospital | Beijing | Beijing Municipality | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | China |
| Sir Run Run Shaw Hospital,ZheJiang University School Of Medicine | Zhejiang | Hangzhou | China |
| The First Hospital Of Hebei Medical University | Shijiazhuang | Hebei | China |
| The First Affiliated Hospital Of Zhengzhou University | Zhengzhou | Henan | China |
| Wuhan Hospital Of Traditional Chinese And Western Medicine | Wuhan | Hubei | China |
| The Second Xiangya Hospital Of Central South University | Changsha | Hunan | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| The First Hospital Of China Medical University | Shenyang | Liaoning | China |
| Huashan Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | China |
| West China Hospital Sichuan University | Chengdou | Sichuan | China |
| Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| Affiliated Hangzhou First People's Hospital,Zhejiang University School Of Medicine | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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