NCT01376037

Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference

An Evaluation of the Effectiveness of the Erchonia ML Scanner (MLS) as a Non-invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of the Upper Arms Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (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 the Erchonia® ML Scanner (MLS) low level light laser device can help to reduce the circumference of the upper arms.

Detailed description

Upper arm body contouring is designed to remove excess skin and/or fatty tissue from the upper arms. Cosmetic procedures are growing in prevalence, upper arm body contouring procedures increased 4059% from 2000 to 2008, and in 2009, just over 16,100 upper arm lifts were performed in the United States (U.S.). Currently available procedures to reduce upper arm circumference include brachioplasty (arm lift), a surgical procedure to remove excess skin and fatty tissue from the upper arm; liposuction of localized fatty deposits in the upper arm; and diet and exercise to reduce excess body fat. Both brachioplasty and liposuction are surgical procedures with risks and potential complications including trauma; fluid accumulation requiring drainage; injury to the skin; infection; permanent scars; and complications from anesthesia. Low level laser light therapy offers a safe, non-invasive and essentially risk-free alternative to reducing upper arm circumference. The device being evaluated for the reduction of upper arm circumference, the Erchonia ML Scanner (MLS) is cleared by the Food and Drug Administration (FDA) under K082609 for "... use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs." Furthermore, FDA identifies this generic type of device as: "A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use." Therefore, the biochemical effect of the Erchonia® MLS low level laser light therapy device stimulates the mitochondria of the adipocyte cells which in turn increases the production of Adenosine-5'-triphosphate (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.

Conditions

• Body Contouring

Interventions

Type	Name	Description
DEVICE	Erchonia(r) ML Scanner (MLS)	The Erchonia ML Scanner (MLS) low level laser light therapy device is administered to both arms for 20 minutes each, 6 times across 2 weeks.
DEVICE	inactive placebo laser device	non-therapeutic light application

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-06-20
• Last updated: 2014-05-30
• Results posted: 2013-05-29