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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867150
• Other study ID #: MLS-1510
• Status: Completed
• Phase: N/A
• First received: January 3, 2016
• Last updated: June 16, 2017
• Start date: October 2015
• Est. completion date: October 2015

Study information

• Verified date: June 2017
• Source: Ward Photonics 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 635nm 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 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Ward Photonics Photonica Professional
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ward Photonics LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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