A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-498 in Female Patients With Androgenetic Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Total number of hair Changes
研究概览
简要总结
This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia
详细描述
Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 54 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female of age 19-54 years
- •Clinical Diagnosis of Androgenetic Alopecia
- •Written informed consent
排除标准
- •Other types of Alopecia or other diseases that can cause hair loss
- •Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
- •Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
- •Women who are pregnant or breastfeeding
- •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug
研究组 & 干预措施
Test Group1
干预措施: CKD-498 dose#1 (Drug)
Test Group1
干预措施: Placebo of CKD-498 dose#2 (Drug)
Test Group1
干预措施: Placebo of CKD-498 dose#3 (Drug)
Test Group2
干预措施: CKD-498 dose#2 (Drug)
Test Group2
干预措施: Placebo of CKD-498 dose#1 (Drug)
Test Group2
干预措施: Placebo of CKD-498 dose#3 (Drug)
Test Group3
干预措施: CKD-498 dose#3 (Drug)
Test Group3
干预措施: Placebo of CKD-498 dose#1 (Drug)
Test Group3
干预措施: Placebo of CKD-498 dose#2 (Drug)
Placebo Group
干预措施: Placebo of CKD-498 dose#1 (Drug)
Placebo Group
干预措施: Placebo of CKD-498 dose#2 (Drug)
Placebo Group
干预措施: Placebo of CKD-498 dose#3 (Drug)
结局指标
主要结局
Total number of hair Changes
时间窗: Baseline, Week 24
from Baseline at Week24 of total number of hair changes
次要结局
未报告次要终点