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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02867150
Other study ID # MLS-1510
Secondary ID
Status Completed
Phase N/A
First received January 3, 2016
Last updated June 16, 2017
Start date October 2015
Est. completion date October 2015

Study information

Verified date June 2017
Source Ward Photonics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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®).


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 74 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ward Photonics LLC

Outcome

Type Measure Description Time frame Safety issue
Primary Fat Reduction in Treatment Zone as Measured in Inches Lost Circumferential measurement of thighs, hips and waist before and after treatment. Single 32-minute treatment session
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