Efficacy of the Use of Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With regenKit BCT-HA Cellular Matrix for Skin in Aesthetic Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Regen Lab SA
- 入组人数
- 31
- 主要终点
- Evaluate the changes of facial apparent overall assessed by FACE-Q scale.
研究概览
简要总结
The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 40 years with chronological aging
- •Completed informed consent form
排除标准
- •Pregnancy or breastfeeding
- •Patients younger than 40 years
- •Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start,
- •patients with known hypersensitivity to HA,
- •patients with eczema flare-up,
- •patients with active skin disorder infection including herpes virus infection, active hepatitis or human infection virus infection.
- •Dermatological diseases affecting the face
- •Auto-immune disease such as Hashimoto, rheumatoid arthritis.
- •Malignancy with or without metastatic disease
- •Chemotherapy
- •Anticoagulant therapy
研究组 & 干预措施
Mesotherapy of PRP-HA into the cheeks
Three sessions of PRP-HA prepared with RegenKit BCT-HA Cellular Matrix into each cheek separated by 1 month interval.
干预措施: Regenkit BCT-HA Cellular Matrix (Device)
结局指标
主要结局
Evaluate the changes of facial apparent overall assessed by FACE-Q scale.
时间窗: 6 months
Evaluate changes in facial apparent assessed by FACE-Q scale after 6 month of Autologous Platelet Rich Plasma combined to hyaluronic acid compared to baseline (before treatment)
次要结局
- Evaluate the changes of skin elasticity assessed by the Cutometer®(6 months)