A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Female Androgenetic Alopecia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in terminal hair follicles in the vertex area
研究概览
简要总结
The goal of this clinical trial is to learn if dihydroartemisinin (DHA) works to treat Androgenetic Alopecia (AGA) in female adults. The main question it aims to answer is:
• Does DHA increase terminal hair follicles in the vertex area. Researchers will compare oral DHA plus topical minoxidil to topical minoxidil alone in female patients with AGA to see if DHA works to alleviate AGA.
Participants will:
- Receive oral DHA every day plus topical minoxidil or use topical minoxidil alone for 6 months.
- Visit the clinic once every month for checkups and tests.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with androgenetic alopecia (AGA)
- •No pregnancy plans within the next 6 months
排除标准
- •Patients who received systemic medications for hair loss within the past 2 months
- •Use of topical medication for hair loss within the past 2 weeks
- •Pregnancy or lactation
- •Patients with known severe diseases of vital organs (e.g., heart, liver, kidney) or malignancies.
研究组 & 干预措施
Intervention Arm
oral dihydroartemisinin (DHA) combined with topical minoxidil
干预措施: Oral DHA + Topical minoxidil 5% (Drug)
Control Arm
topical minoxidil alone
干预措施: Topical Minoxidil 5% (Drug)
结局指标
主要结局
Improvement in terminal hair follicles in the vertex area
时间窗: Baseline and 180-day of treatment
Terminal hair follicles in the vertex area will be quantified before and at the end of treatment
次要结局
- Change of terminal hair follicle density in the vertex area from baseline to the end of treatment(Baseline and 180-day of treatment)
- Change of hair density in the vertex area from baseline to the end of treatment(Baseline and 180-day of treatment)
- Change of terminal hair follicle density in the frontal area from baseline to the end of treatment(Baseline and 180-day of treatment)
- Change of hair density in the frontal area from baseline to the end of treatment(Baseline and 180-day of treatment)
- Change of serum total testosterone from baseline to the end of treatment(Baseline and 180-day of treatment)