A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Calibre & Density of Hair as assessed by Folliscope
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
- •Subjects willing to refrain from other AGA treatments during the entire study duration
- •Subjects who are willing to give informed consent and adhere to the study protocol
排除标准
- •Subjects aged <18 or > 50 years
- •Subjects with dermatological disorder of scalp that might interfere with study evaluation
- •Subjects on Anti-coagulant therapy
- •Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
- •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.
研究组 & 干预措施
Study arm A
Subjects will receive hair follicles transplants that are dipped in HPL before transplant
干预措施: Autologous Human Platelet Lysate (Biological)
Study arm B
Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant
干预措施: Autologous Human Platelet Lysate (Biological)
Control arm C
Subject will receive Standard hair follicle transplant
干预措施: Standard hair follicle transplant (Other)
结局指标
主要结局
Improvement in Calibre & Density of Hair as assessed by Folliscope
时间窗: Day 0, Month 2, End of Study - Month 4
次要结局
- Photographic assessment(Day 0, Month 1, Month 2, Month 3, End of Study - Month 4)