Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Total Wrinkle Length
研究概览
简要总结
Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.
详细描述
10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults more than 21 years of age
- •Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)
排除标准
- •Pregnant women.
- •Psychiatric patients.
- •Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia
- •Anticoagulants(eg.aspirin, warfarin)
- •Had other wrinkle therapy for less than a month.(laser, peels, injections)
- •Had facelift surgery for less than a year.
- •Diseased states such as organ failure, severe anaemia, cancer, acute/chronic infections.
- •Involved in personal litigation against an aesthetic service provider
结局指标
主要结局
Total Wrinkle Length
时间窗: 3 months
All visible wrinkles are measured and the length is summed up to give the Total Wrinkle Length. Comparison of pre treatment and post treatment Total Wrinkle Length will be studied.
次要结局
- Side effect / Adverse Event(3 months)