Platelet Rich Fibrin Versus Platelet Rich Plasma for Microneedling Treatment of Facial Photoaging-a Double Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Global Aesthetic Improvement Scale
研究概览
简要总结
The present study was conducted for analyzing the efficacy and safety of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in photoaging therapy.
Specific arms:
- The investigators will compare the photoaging improvement of PRF and PRP treated face before and after treatment by two blinded investigators.
- The investigators will evaluate the improvement of each parameter of photoaging by Visia system, dermoscope, and optical coherence tomography.
- The investigators will evaluate the safety of the treatment of PRF and PRP.
Each case will receive 3 sessions of injection therapies with one month interval (T0, T1, and T2). Each case will receive PRP therapy on one side of the face and PRF on the other side of face. The investigators will determine the treatment method for both sides of each case randomly by coin flapping before the study. The investigators will evaluate each case before each session of therapy (T0, T1, T2) as well as 1 (T3) and 3 months (T4) after final session of treatment.
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, Investigator, Outcomes Assessor)
盲法说明
The randomization numbers will be generated via SAS software version 9.4 by independent blinded personnel outside our research team. We will use the randomization numbers to determine the treatment method for both sides of each case before the study.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II)
- •The photoaging severity of bilateral face is symmetric.
排除标准
- •Patients with thrombocytopenia, coagulopathy, hematopoietic malignancy.
- •Patients with severe inflammation over treated area, malignancy, keloid, or poor wound healing history.
- •Patients had received laser, radiofrequency, ultherapy over treated area within 6 months.
- •Patients had received botulism or filler injection over treated area within 12 months.
- •Patients had received plastic surgery over treated area within 12 months.
- •Patients had severe psychiatric disorders with poor control.
- •Patients with other diseases which are not suitable for receiving platelet rich plasma (PRP) or platelet rich fibrin (PRF) therapy.
结局指标
主要结局
Global Aesthetic Improvement Scale
时间窗: 3 months after the last session of treatment
We will compare the photoaging improvement of PRF and PRP treated face before treatment and 3 months after last treatment by two blinded investigators using Global Aesthetic Improvement Scale (GAIS). GAIS, which is a 5-point scale wherein 5 = very much improved, 4 = much improved, 3 = improved, 2 = no change, and 1= worse.
次要结局
- Wrinkle Severity Rating scale(3 months after the last session of treatment)
- Fitzpatrick wrinkle scale(3 months after the last session of treatment)
研究者
Yau-Li Huang
Principal Investigator
Chang Gung Memorial Hospital