NCT02280603已完成1 期
A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
研究概览
简要总结
This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia
Design : Randomized, double-blind, active-controlled study
Investigational Product : Finasteride, minoxidil
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 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2
排除标准
- •Evidence of hair loss other than androgenetic alopecia
- •Use of finasteride, dutasteride within previous 12 months
- •Use of minoxidil within previous 6 months
- •Use of androgenic or anti-androgenic agents within previous 6 months
- •Use of steroid agents for local application to scalp or systemic application within previous 1 month
- •History of hair transplantation, scalp reduction
- •Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris
研究组 & 干预措施
DA-4001C
Experimental
DA-4001C is administered
干预措施: DA-4001C (Drug)
5% minoxidil
Active Comparator
5% minoxidil is administered
干预措施: 5% minoxidil (Drug)
结局指标
主要结局
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
时间窗: baseline and week 24
次要结局
- Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram(Baseline and week 16)
- Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram(Baseline, week 16,and week24)
- Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram(Baseline, week 16, and week 24)
研究者
研究点 (1)
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