NCT05135468已完成3 期
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- The Rate of TAHC
研究概览
简要总结
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
- •Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
- •Males aged 18 to 41 years (inclusive);
- •Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details);
- •Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -
排除标准
- •A history of scalp skin abnormalities or scalp skin diseases at the time of screening
- •Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
- •Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
- •Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
- •Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
- •A history of depression, anxiety, personality disorder or other mental disorders;
- •A history of varicocele or infertility ;
- •A history of malignant tumor;
研究组 & 干预措施
CU-40102 Spray
Experimental
0.25% (2.275mg/mL) Finasteride
干预措施: CU-40102 Spray (Drug)
Placebo for CU-40102 Spray
Placebo Comparator
Placebo Spray
干预措施: CU-40102 Spray (Drug)
结局指标
主要结局
The Rate of TAHC
时间窗: 24 weeks.
the change from baseline in target area hair count (TAHC) in the vertex after treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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