Effects of Red Light LED Therapy on Body Contouring
试验速览
- 阶段
- 不适用
- 发起方
- Manamed Inc.
- 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
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.
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 one 28 minute treatment period. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.
The FB Professional therapy program uses the FB Professional LED device for fat removal using LED red light therapy. This multi-site study reviews results from 70 randomly selected patients after a single treatment using the FB Professional 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.
研究组 & 干预措施
Active Device
Active Device: The FB Professional LED red light therapy system
FB Professional is a treatment regime using the FB Professional device for fat removal using red light therapy.
Intervention device: FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.
干预措施: FB Professional LED Red light therapy (Device)
Active Device
Active Device: The FB Professional LED red light therapy system
FB Professional is a treatment regime using the FB Professional device for fat removal using red light therapy.
Intervention device: FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.
干预措施: Effects of Red Light LED Therapy on Body Contouring (Device)
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 session
Circumferential measurement of thighs, hips and waist before and after treatment.
次要结局
未报告次要终点