NCT01292538

Study of the Effectiveness of Green Diode Laser Light on Body Shaping

A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Body Contouring of the Waist, Hips and Thighs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if 532nm green diode laser light is effective in body contouring of the waist, hips and thighs.

Detailed description

Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. However, while the demand for body shaping procedures is constantly on the rise, so is the demand for such procedures to be performed more quickly, simply and most importantly, less invasively; hence the growing popularity of non- to minimally-invasive cosmetic surgery procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were performed, a 35% increase from 2000. In recent years, Erchonia Corporation, a manufacturer of low level lasers, has developed a dual-diode laser that emits 532 nm and 635nm collimated line-generated beams to emulsify fat. In August, 2010, the Erchonia® ML Scanner (MLS) 635nm was cleared by FDA for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. It was determined that the biochemical effect of the Erchonia® MLS stimulates the mitochondria of the adipocyte cells which in turn increases the production of ATP. The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to pass across the membrane and into extra-cellular space. Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-cellular space. This pilot study will apply the Erchonia® MLS employing 532 nm green diodes in lieu of 635 nm red diodes to compare the results to those attained using the 635 nm diodes. The Sponsor believes the use of 532 nm diodes may prove as effective as 635 nm diodes combined with a reduction in total procedure administration time from 40 to 30 minutes. It is the goal of this study to evaluate this hypothesis.

Conditions

• Body Contouring

Interventions

Type	Name	Description
DEVICE	Erchonia GLS	532 nm green diode low level laser light device
DEVICE	Placebo laser	Sham light output with no therapeutic benefit

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-02-09
• Last updated: 2020-02-10
• Results posted: 2014-06-03

Locations

2 sites across 1 country: United States