A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Improvement in Facial Wrinkles
研究概览
简要总结
This is a retrospective chart review of data from the multi-site prospective clinical trial, "Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002)" to evaluate the safety and efficacy of the Profound Matrix System Matrix Pro applicator for the treatment of wrinkles.
详细描述
This was a retrospective medical record review of subject data from the source study FUFT2002 to evaluate the safety, efficacy, tolerability, and usability of the Profound MatrixTM System with the Matrix Pro Applicator for the treatment of wrinkles.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Met eligibility criteria under source study FUFT2002 and enrolled into FUFT2002 study (NCT # pending).
- •Received full face treatment with 27W Matrix Pro applicator only.
- •Have baseline and follow-up assessments obtained.
- •Have photography obtained with the VISIA standardized camera system (Appendix III).
排除标准
- •Sun exposure during the course of the study.
- •Aesthetic procedures and/or treatments during the course of the study.
- •Any violation of study treatment instructions.
- •Upon inspection, any differences in baseline and follow up photos that would not make evaluation of photos viable (e.g. chin placement, facial expression).
- •Any protocol deviation or change in study visit activities that would jeopardize reliability or validity of the retrospective review
结局指标
主要结局
Improvement in Facial Wrinkles
时间窗: Approximately 6 months following baseline assessment
Improvement in the appearance of wrinkles was assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 3-month follow-up (post final treatment). Success for an individual subject (an individual responder) was determined if at least two out of three evaluators correctly identified the post-treatment photograph by selecting the correct corresponding photograph side (left or right).
次要结局
- Subject Global Aesthetic Improvement Scale (GAIS)(Approximately 6 months following baseline assessment)
- Subject Global Aesthetic Improvement Scale (SGAIS)(Approximately 4 months following baseline assessment)