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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ward Photonics LLC
ClinicalTrials.gov Identifier:
NCT02867150
First received: January 3, 2016
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Obesity Device: Ward Photonics Photonica Professional

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring

Further study details as provided by Ward Photonics LLC:

Primary Outcome Measures:
  • 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.


Enrollment: 58
Study Start Date: October 2015
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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®).

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02867150

Sponsors and Collaborators
Ward Photonics LLC
Investigators
Principal Investigator: Terry J Ward, M.H.A. Managing Director
  More Information

Responsible Party: Ward Photonics LLC
ClinicalTrials.gov Identifier: NCT02867150     History of Changes
Other Study ID Numbers: MLS-1510
Study First Received: January 3, 2016
Results First Received: August 18, 2016
Last Updated: June 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.

ClinicalTrials.gov processed this record on September 21, 2017