Effects of Red Light LED Therapy on Body Contouring
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Manamed Inc.
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 77 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 18 years or older.
- •May be male or female.
- •Generally good health.
Exclusion Criteria
- •Open wounds or sores.
- •Pacemaker.
- •Photosensitivity.
- •Epilepsy.
- •Any form of cancer.
- •Severe kidney or liver problems.
- •Thyroid problems.
- •Pregnant or nursing.
Arms & Interventions
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.
Intervention: FB Professional LED Red light therapy (Device)
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.
Intervention: Effects of Red Light LED Therapy on Body Contouring (Device)
Outcomes
Primary Outcomes
Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
Time Frame: One 28 minute session
Circumferential measurement of thighs, hips and waist before and after treatment.
Secondary Outcomes
No secondary outcomes reported