Study of Low Level Laser Light Therapy on Circumference Reduction
Condition: Circumference Reduction
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, thighs and upper abdomen over a 6 week period.
    

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 significantly increased from 2010 to 2011, the overall
      growth in cosmetic procedures is primarily driven by a substantial rise in minimally-invasive
      procedures, that 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 offers a simple, non-invasive, safe, effective and side-effect
      free alternative to achieving body circumference reduction.

      Justification for the assertion of anticipated safety and effectiveness of application of the
      Erchonia® EZ6 Laser low level laser therapy for the reduction of body circumference is found
      through three Food and Drug Administration (FDA) clearances for Erchonia® Low Level Laser
      devices for body circumference reduction indications, as follows:

      K123237 (532 nanometer (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: 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. The
      intended application/indication of the EZ6 in this study is comparable to the above
      FDA-cleared indications, with the study intent being to evaluate the comparative efficacy of
      a six week, once weekly 60 minute treatment administration protocol employing 6 red light
      diodes to the established efficacy of the current two week, thrice weekly 40 minute treatment
      administration protocol with application of five red light diodes on reduction of hips,
      waist, thighs and upper abdomen circumference.
    

Intervention name(s): Erchonia EZ6 Laser
Intervention type(s): Device
Intervention description(s): The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
Other intervention name(s): Erchonia® Zerona 6 Headed Scanner
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: body contouring; body shaping; circumference reduction