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This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.
Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KX-826-2.5 mg BID | Experimental | treatment dose groups of 2.5 mg BID (0.25%) |
|
| KX-826-5 mg QD | Experimental | treatment dose groups of 5 mg QD (0.5%) |
|
| KX-826-5 mg BID | Experimental | treatment dose groups of 5 mg BID (0.5%) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KX-826-2.5 mg (0.25%)/60 mL BID | Drug | Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered 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). | change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24). | mean change from baseline after 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment | Hair growth assessment (HGA), including patient self-assessment, investigator assessment, and third-party professional physician assessment | change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method |
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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 |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | China | |||
| Peking University People's Hospital |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
|
| KX-826-5 mg (5%)/60 mL QD | Drug | Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily. |
|
| KX-826-5 mg (5%)/60 mL BID | Drug | Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening. |
|
| Placebo | Other | Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm),starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily for QD dose groups, and once in the morning and once in the evening for the BID dose groups. |
|
| Change in non-vellus hair diameter (width) in the target area (TAHW) (change from baseline at Weeks 6, 12, 18, 24 of treatment) | 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 |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Huashan Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |