A Prospective, Multicentric, Open Label, Randomized, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA) In Patients Undergoing Hair Transplantation
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 1.Increase in Hair Follicle viability after transplant
研究概览
简要总结
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, Improvement in Caliber & Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects, aged between 18 to 50 years (both inclusive) and in general good health 2.Subjects willing to refrain from other AGA treatments during the entire study duration 3.Subjects who are willing to give informed consent and adhere to the study protocol.
排除标准
- •1.Subjects aged <18 or > 50 years
- •Subjects with dermatological disorder of scalp that might interfere with study evaluation 3.Subjects on Anti-coagulant therapy
- •Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
- •5.Subjects unwilling to or unable to comply with the study protocol.
- •Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.
结局指标
主要结局
1.Increase in Hair Follicle viability after transplant
时间窗: End Of Study - 4 Months
2.Improvement in Calibre & Density of Hair as assessed by Folliscope
时间窗: End Of Study - 4 Months
3. Photographic assessment from randomization to end of study
时间窗: End Of Study - 4 Months
次要结局
- 1.Physician’s assessment score(2.Patients self assessment score)