Effects of Red Light LED Therapy on Body Contouring

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242564
• Other study ID #: Vev-2017-1
• Status: Completed
• Phase: N/A
• First received: July 26, 2017
• Last updated: August 3, 2017
• Start date: July 10, 2017
• Est. completion date: July 21, 2017

Study information

• Verified date: August 2017
• Source: Vevazz, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 21, 2017
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Vevazz LED
Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.

Locations

Country	Name	City	State
United States	Vevazz, LLC	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vevazz, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 treatment session.