Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference
Condition: Body Contouring
Study type: Interventional

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.
    

Intervention name(s): Erchonia(r) ML Scanner (MLS); inactive placebo laser device
Intervention type(s): Device; Device
Intervention description(s): 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.; non-therapeutic light application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: upper arm; body contouring; body shaping