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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 740
- 试验地点
- 26
- 主要终点
- change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study, and sign the ICF in writing;
- •Male, ≥ 18 old;
- •Clinically diagnosed as androgenetic alopecia;
- •Rating IIIv, IV and V on Hamilton-Norwood scale;
排除标准
- •Have used androgen replacement therapy, immunosuppressants, corticosteroids and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
- •Have used minoxidil within 6 months prior to screening;
- •Have used finasteride or dutasteride within 12 months prior to screening;
- •Had used topical drugs for alopecia sites within 3 months prior to screening;
- •Have received scalp radiation and/or laser or surgical therapy within 12 months prior to screening;
- •Those who, in the opinion of the investigator, have other conditions that may affect compliance or are not suitable for participation in this study.
研究组 & 干预措施
KX-826-0.5% BID
treatment dose group of 0.5% BID(0.5%)
干预措施: KX-826-（5%） BID (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
时间窗: mean change from baseline after 24 weeks of treatment
change in non-vellus hair count in the target area (TAHC, mean change from baseline at Week 24 in comparison to placebo).
次要结局
- 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)
- Secondary Outcome Measure:(change from baseline after 6, 12, 18, and 24 weeks of treatment, assessed using a 7-category method)