A Retrospective Analysis of the Effects of Red Light LED Therapy on Body Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vevazz, LLC
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
研究概览
简要总结
The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.
详细描述
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.
Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.
The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.
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 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years or older.
- •May be male or female.
- •Generally good health.
排除标准
- •Open wounds or sores.
- •Pacemaker.
- •Photosensitivity.
- •Epilepsy.
- •Any form of cancer.
- •Severe kidney or liver problems.
- •Thyroid problems.
- •Pregnant or nursing.
结局指标
主要结局
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
时间窗: One 28 minute treatment session.
Circumferential measurement of thighs, hips and waist before and after treatment.
次要结局
未报告次要终点