A Randomized, Split-head Comparison Study of the Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Trichoscan
研究概览
简要总结
The goal of this clinical trial is to compare between platelet-rich fibrin and platelet-rich plasma in female pattern hair loss . The main question[s] it aims to answer are:
- efficacy between platelet-rich fibrin and platelet-rich plasma
- safety between platelet-rich fibrin and platelet-rich plasma Participants will be divided into 2 side of treatment with composed of
- Platelet rich plasma
- Platelet rich fibrin
详细描述
Subject was treated both platelet-rich fibrin and platelet-rich plasma for 3 times which 1 month interval then will be followed up at 4 months and 6 months after last treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-55 years
- •Subject who was diagnosed with Female pattern hair loss in Ludwig Classification 2 (part width 2-4 centimeters) by Dermatologist
排除标准
- •Pregnancy or Lactation subjects
- •Subject with history of platelet dysfunction, low platelet, anemia, cirrhosis, cancer, or immunocompromised host
- •Subject who are active smoking and alcoholism
- •Subject who has dermatitis, scar or infection at intervention area
- •Subject who has history of allergy to anesthesia drug
- •Subject who taking NSAIDs, Hormonal drug, anticoagulants drug
- •Subject who has psychiatric condition diagnosed by psychiatrist
- •Subject who are not allowed to take a photo
研究组 & 干预措施
PRF and PRP
All patients were treated with both platelet rich fibrin and platelet rich plasma but each side of head (left or right) was split with
- one side of head was injected with platelet rich plasma at week 0,4 and 8 (total 3 times)
- another side of head was injected with platelet rich fibrin at week 0,4 and 8 (total 3 times)
干预措施: Platelet rich fibrin (Device)
PRF and PRP
All patients were treated with both platelet rich fibrin and platelet rich plasma but each side of head (left or right) was split with
- one side of head was injected with platelet rich plasma at week 0,4 and 8 (total 3 times)
- another side of head was injected with platelet rich fibrin at week 0,4 and 8 (total 3 times)
干预措施: Platelet rich plasma (Device)
结局指标
主要结局
Trichoscan
时间窗: baseline(week0), 4 months after last treatment(week20), 6 months after last treatment(week28)
Average counts and density of hair per 1.5mm\^2
次要结局
- Visual analog scale(baseline(week0), 1 month after first treatment(week4), 1 months after second treatment(week8))
- The 7-point of doctor subjective global assessment(baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28))
- The 7-point of patient subjective global assessment(baseline(week0),1 month after first treatment(week4), 1 months after second treatment(week8), 4 months after last treatment(week20), 6 months after last treatment(week28))
研究者
Rattapon Thuangtong
Associate Professor
Siriraj Hospital