Study to See How Low Level Laser Light Affects Subcutaneous Fat Around the Hips and Waist

Weight Loss Clinical Trial

Official title: An Evaluation of the Effect of the Erchonia ML Scanner (MLS) as Applied to Body Contouring of the Waist and Hips on Fat Emulsification Pilot Study.

Status Withdrawn

Clinical Trial Summary

The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.

Clinical Trial Description

Laser therapy provides an alternative therapeutic regimen for the reduction of subcutaneous tissue volume. Although the biochemical mechanism is not yet fully understood, histological studies clearly and effectively identify the formation of the transitory pore and subsequent cell collapse immediately following laser irradiation. More importantly, a placebo-controlled, randomized, double-blind clinical investigation using the Erchonia MLS with 67 enrolled participants revealed a statistically significant reduction of overall circumference measurements of the waist, hip, and thighs following two weeks of treatment, resulting in Food and Drug Administration (FDA) clearance for the indication.

Laser therapy operates under the principle of photochemistry, activating and/or suppressing natural biochemical processes. Because Low Level Laser Therapy (LLLT) does not induce cellular apoptosis, there is no upregulation of pro-inflammatory cytokines nor is there a large burden placed on the lymphatic system. The fatty material secreted from the adipocytes following laser irradiation are absorbed by the lymphatic system, broken down by the liver, and naturally secreted. Fatty acids released are bound to albumin, and are transported through the circulatory system to the liver to undergo fatty acid oxidation. The triglycerides released are bound as lipoproteins and transported to the liver to be processed. Moreover, a lipase known as lipoprotein lipase, has been demonstrated to breakdown emulsified triglycerides; therefore breaking the molecule down into three fatty acids and one glycerol molecule. The most important aspect of laser therapy is that cellular apoptosis is not induced. The fatty material being evacuated from the cell must be absorbed by the lymphatic system, and because laser therapy does not destroy the cell, the complex organelles and the entire cell structure will not be absorbed by the lymphatic system. It is not well understood how much the lymphatic system can absorb; therefore, creating a mass amount of cellular debris by destroying adipose tissue may result in serious long term effects. Moreover, adipose tissue is not just composed of fat storing cells; there is also a collection of immune cells, fibroblasts, vessels, and stromal stem cells. By creating the transitory pore in the fat storing cell only, the viability of the surrounding, non-fat storing cells is preserved.

The purpose of this pilot study is to demonstrate and document the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Loss

• NCT number: NCT01292564
• Study type: Interventional
• Source: Erchonia Corporation
• Status: Withdrawn
• Phase: N/A
• Start date: February 2011
• Completion date: August 2012