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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Ward Photonics Photonica Professional

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Device; Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ward Photonics LLC
• Investigators: Principal Investigator: Terry J Ward, M.H.A., Managing director

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 3, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MLS-1510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No current plan to share data.