Study of Low Level Laser Light Therapy on Circumference Reduction

Circumference Reduction Clinical Trial

Official title: An Evaluation of the Effect of the Erchonia® Zerona 6 Headed Scanner (EZ6) Six-week Treatment Protocol on Circumference Reduction of the Waist, Hips, Thighs and Upper Abdomen Clinical Study Protocol

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Circumference Reduction

• NCT number: NCT02109107
• Study type: Interventional
• Source: Erchonia Corporation
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: November 2014