A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring

Study Overview
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Brief Summary
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The purpose of this study is to determine whether red light therapy using LED 635nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

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 635nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when performed using a specified treatment protocol. Furthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by Erchonia) achieves its results after six treatments combined with a diet and exercise regimen. UltraSlim Cold Light® is a patented process using the Photonica Professional device for fat removal using LED red light therapy. This multi-site study reviews results from 58 randomly selected patients after a single treatment using the Photonica Professional device (i.e. UltraSlim Cold Light®).

Official Title
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A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring

Conditions
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Obesity

Intervention / Treatment
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* Device: Ward Photonics Photonica Professional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Male or female. Generally good health. Exclusion Criteria: Pregnancy. Active cancer within the past year. Diminished ability to void waste (liver or kidneys). Photosensitive condition or medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 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: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional | Device: Ward Photonics Photonica Professional<br>* Active Device: Ward Photonics, Photonica Professional Red light therapy system UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Reduction in Treatment Zone as Measured in Inches Lost | Circumferential measurement of thighs, hips and waist before and after treatment. | Single 32-minute treatment session |