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临床试验/NCT04825561
NCT04825561已完成3 期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia

Addpharma Inc.1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2021年6月9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
已完成
入组人数
139
试验地点
1
主要终点
The amount of Change in the total number of hairs

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of AD-208.

详细描述

The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.

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 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients aged 18-50 years, inclusive
  • Patients who meet the appropriate criteria according to the classification of hair loss
  • Signed informed consent

排除标准

  • Patients with hair loss disorders other than androgenetic alopecia
  • Other exclusions applied

研究组 & 干预措施

Active Comparator

Active Comparator

AD-208 and Placebo of AD-2081

干预措施: AD-208 (Drug)

Active Comparator

Active Comparator

AD-208 and Placebo of AD-2081

干预措施: placebo of AD-2081 (Drug)

Placebo Comparator

Placebo Comparator

Placebo of AD-208 and Placebo of AD-2081

干预措施: placebo of AD-208 (Drug)

Placebo Comparator

Placebo Comparator

Placebo of AD-208 and Placebo of AD-2081

干预措施: placebo of AD-2081 (Drug)

Experimental Comparator

Experimental

Placebo of AD-208 and AD-2081

干预措施: AD-2081 (Drug)

Experimental Comparator

Experimental

Placebo of AD-208 and AD-2081

干预措施: placebo of AD-208 (Drug)

结局指标

主要结局

The amount of Change in the total number of hairs

时间窗: Baseline, Week 24

The amount of change in the total number of hairs in the unit area

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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