Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether low level laser light therapy is effective
      in reducing circumference of the waist, hips and upper abdomen in obese individuals.
    

Detailed description: 
      The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for
      cosmetic procedures has shown significant growth over the past two years, with 13.8 million
      cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010.
      While surgical cosmetic procedures did increase significantly from 2010 to 2011, the overall
      growth in cosmetic procedures is being primarily driven by a substantial rise in
      minimally-invasive procedures. Cosmetic minimally-invasive procedures increased 6%, with
      nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011.
      This highlights the growing consumer demand for non- or minimally-invasive cosmetic
      procedures that do not involve surgical procedures such as liposuction and the associated
      risks, potential complications and lengthy and painful recovery processes.

      Low level laser light therapy, such as that to be provided through application of the
      Erchonia® Obesity Laser in this clinical study protocol, offers a simple, non-invasive, safe,
      effective and side-effect free alternative to achieving body circumference reduction.

      Justification for this assertion of anticipated safety and effectiveness of the application
      of the Erchonia® Obesity Laser for the reduction of body circumference is found through three
      FDA clearances for Erchonia® Low Level Laser devices for body circumference reduction
      indications, as follows:

      K123237 (532 nm green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a
      non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to
      undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

      K121695 & K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) & Erchonia® Zerona:
      is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for
      individuals intending to undergo liposuction procedures for the reduction of circumference of
      hips, waist, and thighs.

      K121690 & K120257 (635 nm red light diodes): Erchonia® MLS, Zerona, Zerona-AD: is indicated
      for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals
      intending to undergo liposuction procedures for the reduction of circumference of the upper
      arms.

      Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for
      application for body circumference reduction indications for multiple body areas, such that
      evaluation of application of the Erchonia Obesity Laser to reducing body circumference in
      more overweight individuals is a natural extension of its proven and accepted application for
      body circumference reduction purposes.
    

Intervention name(s): Erchonia Obesity Laser; Placebo Laser
Intervention type(s): Device; Device
Intervention description(s): 10 independent 17 milliwatts 532 nm green diode lasers; Emits light that has no therapeutic effect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment