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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02867150
First Posted: August 15, 2016
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ward Photonics LLC
January 3, 2016
August 15, 2016
August 18, 2016
June 23, 2017
June 23, 2017
October 2015
October 2015   (Final data collection date for primary outcome measure)
Fat Reduction in Treatment Zone as Measured in Inches Lost [ Time Frame: Single 32-minute treatment session ]
Circumferential measurement of thighs, hips and waist before and after treatment.
Same as current
Complete list of historical versions of study NCT02867150 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
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.

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®).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obesity
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.

Experimental: Active Device
Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional
Intervention: Device: Ward Photonics Photonica Professional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
October 2015
October 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02867150
MLS-1510
Yes
Not Provided
Plan to Share IPD: No
Plan Description: No current plan to share data.
Ward Photonics LLC
Ward Photonics LLC
Not Provided
Principal Investigator: Terry J Ward, M.H.A. Managing Director
Ward Photonics LLC
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP