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

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.
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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Intervention Device: Ward Photonics Photonica Professional
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Device
Hide Arm/Group Description

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

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.

Period Title: Overall Study
Started 58
Completed 58
Not Completed 0
Arm/Group Title Active Device
Hide Arm/Group Description

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

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.

Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
<=18 years
1
   1.7%
Between 18 and 65 years
54
  93.1%
>=65 years
3
   5.2%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants
43.3
(18 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
46
  79.3%
Male
12
  20.7%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants
58
[1]
Measure Description: Multi-site U.S. Study
1.Primary Outcome
Title Fat Reduction in Treatment Zone as Measured in Inches Lost
Hide Description Circumferential measurement of thighs, hips and waist before and after treatment.
Time Frame Single 32-minute treatment session
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Device
Hide Arm/Group Description:

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

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.

Overall Number of Participants Analyzed 58
Mean (Full Range)
Unit of Measure: inch
3.5
(1.625 to 10)
Time Frame 6 MONTHS
Adverse Event Reporting Description

No observations of any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research.

Types of adverse events monitored: "All-Cause Mortality," "Serious," and "Other (Not Including Serious)" Adverse Events.

 
Arm/Group Title Active Device
Hide Arm/Group Description

Active Device: Ward Photonics Photonica Professional Red light therapy system Intervention: Device: Ward Photonics Photonica Professional

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.

All-Cause Mortality
Active Device
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Device
Affected / at Risk (%)
Total   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Device
Affected / at Risk (%)
Total   0/58 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ellyn Levine M.D.
Organization: Optimal Health and Weight Center
Phone: (619) 567-6914
Responsible Party: Ward Photonics LLC
ClinicalTrials.gov Identifier: NCT02867150     History of Changes
Other Study ID Numbers: MLS-1510
First Submitted: January 3, 2016
First Posted: August 15, 2016
Results First Submitted: August 18, 2016
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017