NCT07080931招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Efficacy and Safety of 5% Minoxidil Foam in the Treatment of Female Androgenetic Alopecia
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2025年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of once-daily 5% minoxidil foam versus placebo in female androgenetic alopecia, using the Target Area Terminal Hair Count (TAHC) as the primary endpoint.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the study and be able to provide a written Informed Consent Form (ICF);
- •Female aged ≥ 18 years;
- •Investigator-diagnosed androgenetic alopecia;
- •Hair loss severity graded D3 to D6 on the Savin scale;
- •Willingness to maintain identical hairstyle, hair color, and hair length at each follow-up visit;
- •No pregnancy plans during the study and for 3 months post-last dose, with commitment to highly effective contraception. Women of childbearing potential must have negative serum pregnancy test ≤7 days prior to first investigational product administration
排除标准
- •Trial participants with known hypersensitivity to minoxidil or any excipient of the investigational product.
- •Trial participants with known hair loss disorders other than androgenetic alopecia (AGA)
- •Trial participants with any scalp disorder at screening that may interfere with efficacy evaluation, as determined by the investigator.
- •Lactating women
- •Trial participants with history of hypotension or uncontrolled hypertension
- •Trial participants with clinically significant abnormal laboratory findings at screening that may compromise efficacy and safety assessments, as determined by the investigator.
- •Trial participants with clinically significant ECG abnormalities at screening
- •Trial participants with history of malignancy prior to screening.
- •Trial participants known to have conditions or disorders that may affect hair growth or compromise study results.
- •Trial participants with history of using systemically administered therapeutic drugs prior to screening that may interfere with efficacy evaluation, etc.
- •Trial participants with history of topical minoxidil application to alopecia-affected areas prior to screening.
- •Trial participants with no response to prior minoxidil treatment for alopecia
- •Trial participants with history of 5α-reductase inhibitor use prior to screening.
- •Trial participants with history of spironolactone or cyproterone treatment prior to screening.
- •Trial participants with history of autologous platelet-rich plasma (PRP) administration prior to screening.
- •Trial participants with history of chemotherapy, cytotoxic agents, scalp radiation, and/or low-level laser therapy (LLLT) or surgical scalp procedures for FAGA prior to screening.
- •Trial participants with history of using medical shampoos or solutions containing ingredients or other components that may interfere with efficacy evaluation prior to screening.
- •Trial participants planning hair transplantation during the study period, or using hair weaving, non-breathable wigs, or hair bonding during treatment.
- •Trial participants in other interventional clinical trials within 3 months before screening (excluding non-interventional studies and screen failures) , or planned concurrent clinical trial enrollment.
- •Trial participants with history of major surgery within 3 months before screening or planning major surgery during the study period.
- •Trial participants deemed by the investigator to have other conditions that may compromise compliance or render them unsuitable for the study.
研究组 & 干预措施
Placebo for 5% Minoxidil Foam
Placebo Comparator
干预措施: Placebo for 5% Minoxidil Foam (Drug)
5% Minoxidil Foam
Experimental
干预措施: 5% minoxidil foam (Drug)
结局指标
主要结局
Change from baseline in Target Area Hair Count (TAHC) at Week 24, assessed via digital phototrichogram analysis in trial participa
时间窗: Week 24
次要结局
- Mean change from baseline in Target Area Hair Count (TAHC) at Weeks 6, 12, and 18(Weeks 6, 12, and 18)
- Percent change from baseline in Target Area Hair Count (TAHC) at Weeks 12 and 24(Weeks 12 , 24)
- Self-assessed satisfaction scores at Weeks 6, 12, 18, and 24(Weeks 6, 12, 18, 24)
研究者
研究点 (1)
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