Effects of Red Light LED Therapy on Body Contouring
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|ClinicalTrials.gov Identifier: NCT03470272|
Recruitment Status : Unknown
Verified August 2018 by Manamed Inc..
Recruitment status was: Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: FB Professional LED Red light therapy Device: Effects of Red Light LED Therapy on Body Contouring||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Red Light LED Therapy on Body Contouring|
|Estimated Study Start Date :||September 30, 2018|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
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 Name: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470272
|Contact: Mark Julianfirstname.lastname@example.org|
|United States, Florida|
|New Port Richey, Florida, United States, 34654|
|Principal Investigator:||Paul Ligertwood, Dr||Human Studies Group|