Effects of Red Light LED Therapy on Body Contouring

Not Applicable

• Conditions: Obesity
• Interventions: Device: FB Professional LED Red light therapy; Device: Effects of Red Light LED Therapy on Body Contouring

• Registration Number: NCT03470272
• Lead Sponsor: Manamed Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17
• Study Start: 2018-09-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Device	Effects of Red Light LED Therapy on Body Contouring	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.
Active Device	FB Professional LED Red light therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ligertwood Chiropractic; 🇺🇸 New Port Richey, Florida, United States