Effects of Red Light LED Therapy on Body Contouring

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Red Light LED Therapy on Body Contouring

Conditions
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Obesity

Intervention / Treatment
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* Device: FB Professional LED Red light therapy
* Device: Effects of Red Light LED Therapy on Body Contouring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years or older. May be male or female. Generally good health. Exclusion Criteria: Minors. Open wounds or sores. Pacemaker. Photosensitivity. Epilepsy. Any form of cancer. Severe kidney or liver problems. Thyroid problems. Pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Device<br>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. | Device: FB Professional LED Red light therapy<br>* FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Measure before and after effects of device unit. Three measurements before of circumference of abdomen area and three measurements after comparing the results.<br>* Other names: Effects of Red Light LED Therapy on Body Contouring;Device: Effects of Red Light LED Therapy on Body Contouring<br>* Intervention is to take a sample and measure before and after using a sham unit (placebo) and take three measurements of abdominal before treatment and three measurements after sham treatment and compare to controlled treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost | Circumferential measurement of thighs, hips and waist before and after treatment. | One 28 minute session |