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

NCT ID: NCT02867150

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-10-31

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.

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®).

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Device

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

Group Type: EXPERIMENTAL

Ward Photonics Photonica Professional

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ward Photonics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry J Ward, M.H.A.

Role: PRINCIPAL_INVESTIGATOR

Managing Director

Other Identifiers

MLS-1510

Identifier Type: -

Identifier Source: org_study_id