Effects of Red Light LED Therapy on Body Contouring

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 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: FB Professional LED Red light therapy; Device: Effects of Red Light LED Therapy on Body Contouring

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 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after one 28 minute treatment period. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.

The FB Professional therapy program uses the FB Professional LED device for fat removal using LED red light therapy. This multi-site study reviews results from 70 randomly selected patients after a single treatment using the FB Professional LED device.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Julian; Phone Number: 7276419399; Email: glacierheat1@gmail.com

Study Locations

• United States
  • Florida
    • New Port Richey, Florida, United States, 34654
      • Ligertwood Chiropractic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years or older.
• May be male or female.
• Generally good health.

Exclusion Criteria:

• Minors.
• Open wounds or sores.
• Pacemaker.
• Photosensitivity.
• Epilepsy.
• Any form of cancer.
• Severe kidney or liver problems.
• Thyroid problems.
• Pregnant or nursing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Active Device; Active Device: The FB Professional LED red light therapy system FB Professional is a treatment regime using the FB Professional device for fat removal using red light therapy. Intervention device: FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.

Device: FB Professional LED Red light therapy; FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Measure before and after effects of device unit. Three measurements before of circumference of abdomen area and three measurements after comparing the results.; Other Names: Effects of Red Light LED Therapy on Body Contouring; Device: Effects of Red Light LED Therapy on Body Contouring; Intervention is to take a sample and measure before and after using a sham unit (placebo) and take three measurements of abdominal before treatment and three measurements after sham treatment and compare to controlled treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost	Circumferential measurement of thighs, hips and waist before and after treatment.	One 28 minute session

Collaborators and Investigators

• Sponsor: Manamed Inc.
• Investigators: Principal Investigator: Paul Ligertwood, Dr, Human Studies Group

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2018
• Primary Completion (Anticipated): November 30, 2018
• Study Completion (Anticipated): November 30, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Manamed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No