Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
研究概览
简要总结
Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy adults
- •aged 25- 75 years
- •with moderate to severe nasolabial folds
排除标准
- •allergy to local anesthetics
- •history of bleeding disorder
- •active infection at the treatment site
- •injectable filler in the nasolabial folds within past year
结局指标
主要结局
Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
时间窗: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.
Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.
次要结局
- Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week(pre-treatment to 1 week after treatment)
- Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks(Pre-treatment to 2 weeks after treatment)
- Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks(Pre-treatment to 6 weeks after treatment)