Effects of Red Light LED Therapy on Body Contouring

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Vevazz LED

• Registration Number: NCT03242564
• Lead Sponsor: Vevazz, LLC

Brief Summary

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.

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 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.

Study Timeline

• Study Start: 2017-07-10
• Primary Completion: 2017-07-21
• Study Completion: 2017-07-21
• Study First Submitted: 2017-07-26
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-03
• Last Update Submitted: 2017-08-03
• Study First Posted: 2017-08-08
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Device	Vevazz LED	Active Device: Vevazz LED red light therapy system Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy.

Primary Outcome Measures

Name	Time	Method
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost	One 28 minute treatment session.	Circumferential measurement of thighs, hips and waist before and after treatment.

Trial Locations

Locations (1)

Vevazz, LLC; 🇺🇸 Dallas, Texas, United States