A Triple-Blind, Randomized, Efficacy and Tolerability Comparison Study of PDFE-2304 Topical Solution Versus Minoxidil 5% Topical Solution for the Treatment of Androgenic Alopecia (AGA).
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change From Baseline in Target Area Hair Count (TAHC)
研究概览
简要总结
This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PDFE-2304 Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
干预措施: PDFE-2304 Topical Solution (Drug)
Minoxidil 5% Topical Solution
Approximately one mL dose applied onto a pre-specified scalp area twice daily for 16 weeks.
干预措施: Minoxidil 5% Topical Solution (Drug)
结局指标
主要结局
Change From Baseline in Target Area Hair Count (TAHC)
时间窗: Baseline, Week 16 (Day 112)
TAHC is measured using digital imaging analysis and is reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicates improvement (increase in the number of terminal hairs) and a negative change from Baseline indicates worsening (decrease in the number of terminal hairs).
次要结局
- Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score(Week 16 (Day 112))
- Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score(Week 16 (Day 112))
- Change From Baseline in Target Area Hair Width (TAHW)(Baseline, Week 16 (Day 112))
- Change From Baseline in Target Area Hair Darkness (TAHD)(Baseline, Week 16 (Day 112))
- Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score(Week 16 (Day 112))
- Adverse Events(Baseline, Week 16 (Day 112))