Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference
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|ClinicalTrials.gov Identifier: NCT01376037|
Recruitment Status : Completed
First Posted : June 20, 2011
Results First Posted : May 29, 2013
Last Update Posted : May 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Body Contouring||Device: Erchonia(r) ML Scanner (MLS) Device: inactive placebo laser device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Placebo Comparator: inactive placebo laser device
The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.
Device: inactive placebo laser device
non-therapeutic light application
Active Comparator: Erchonia ML Scanner (MLS)
The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter. Six procedures are administered evenly across 2 weeks.
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.
- Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint [ Time Frame: baseline and 2 weeks ]Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).
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): NCT01376037
|Principal Investigator:||Mark S Nestor, M.D.,Ph.D.|
|Principal Investigator:||Shari Sanchez, M.D.||unaffilliated|