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

• 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: Ward Photonics LLC
• Information provided by (Responsible Party): Ward Photonics LLC

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity
• Intervention: Device: Ward Photonics Photonica Professional
• Enrollment: 58

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Active Device
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

Baseline Characteristics

Arm/Group Title		Active Device
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
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

Outcome Measures

1. Primary Outcome

Title	Fat Reduction in Treatment Zone as Measured in Inches Lost
Description	Circumferential measurement of thighs, hips and waist before and after treatment.
Time Frame	Single 32-minute treatment session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Device
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)

Adverse Events

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
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	--/--
Serious Adverse Events
	Active Device
	Affected / at Risk (%)
Total	0/58 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Active Device
	Affected / at Risk (%)
Total	0/58 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: dr.levine@teamtsfl.com

• Responsible Party: Ward Photonics LLC
• ClinicalTrials.gov Identifier: NCT02867150
• 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