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Trial record 1 of 1 for:    NCT02867150
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A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring

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ClinicalTrials.gov Identifier: NCT02867150
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ward Photonics LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Device: Ward Photonics Photonica Professional Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
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
Study Start Date : October 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867150


Sponsors and Collaborators
Ward Photonics LLC
Investigators
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Principal Investigator: Terry J Ward, M.H.A. Managing Director
More Information
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Responsible Party: Ward Photonics LLC
ClinicalTrials.gov Identifier: NCT02867150    
Other Study ID Numbers: MLS-1510
First Posted: August 15, 2016    Key Record Dates
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.