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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Ward Photonics Photonica Professional

• Registration Number: NCT02867150
• Lead Sponsor: Ward Photonics LLC

Brief Summary

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

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®).

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-01-03
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Results First Submitted: 2016-08-18
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-16
• Last Update Submitted: 2017-06-16
• Results First Posted: 2017-06-23
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Device	Ward Photonics Photonica Professional	Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

Primary Outcome Measures

Name	Time	Method
Fat Reduction in Treatment Zone as Measured in Inches Lost	Single 32-minute treatment session	Circumferential measurement of thighs, hips and waist before and after treatment.