Study of Low Level Laser Therapy for Body Contouring

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Body Contouring of the Waist, Hips and Thighs Clinical Study Protocol

The purpose of this study is to determine whether green diode low level laser therapy is effective for body contouring of the waist, hips and thighs.

Study Overview

• Status: Completed
• Conditions: Body Contouring
• Intervention / Treatment: Device: Erchonia ML Scanner (MLS); Device: Sham device

Detailed Description

Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. According to the American Society of Plastic Surgeons (ASPS) statistics, more than 324,000 liposuction procedures, 233,000 eyelid surgeries and 114,000 facelift procedures were performed in 2004 in the United States alone. However, while the demand for body shaping procedures is constantly on the rise, so is the demand for such procedures to be performed more quickly, simply and most importantly, less invasively. Cosmetic surgery patients are no longer satisfied with procedures that require general anesthesia, pose a multitude of potentially serious risks and complications and that require several weeks of recovery time. Hence the growing popularity of non- to minimally-invasive cosmetic surgery procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were performed, a 35% increase from 2000. Consequently, patients and physicians alike are continually searching for non-invasive alternatives to traditional cosmetic procedures such as liposuction that are efficient, safe and effective.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Palm Beach Gardens, Florida, United States, 33410
      • Douglas D. Dedo, MD, FACS
  • Indiana
    • Marion, Indiana, United States, 46952
      • Cosmetic Surgery
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Dr. Gregory C. Roche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• indicated for liposuction for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically in the areas of the waist, hips and bilateral thighs.
• willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
• willing and able to maintain regular diet and exercise regimen without during study participation.
• 18 to 65 years.
• Male or female.

Exclusion Criteria:

• Body Mass Index (BMI) of 30 kg/m² or greater.
• Diabetes dependent on insulin or oral hypoglycemic medications.
• known cardiovascular disease.
• cardiac surgeries, pacemakers.
• excessive alcohol consumption.
• prior surgical intervention for body sculpting/weight loss.
• medical, physical, or other contraindications for body sculpting/weight loss.
• current use of medication(s) known to affect weight levels and/or to cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
• medical condition known to affect weight levels and/or to cause bloating or swelling.
• diagnosis of, and/or taking medication for, irritable bowel syndrome.
• active infection, wound or other external trauma to the areas to be treated with the laser.
• pregnant, breast feeding, or planning pregnancy prior to study end.
• serious mental health illness; psychiatric hospitalization in past two years.
• developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
• involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to weight-related and/or body shape issues.
• participation in research in the past 90 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erchonia ML Scanner (MLS); Red diode low level laser light energy	Device: Erchonia ML Scanner (MLS); Red diode low level laser light energy.
Sham Comparator: Sham device; non-therapeutic sham light output	Device: Sham device; non-therapeutic light energy output

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.	2 weeks

Collaborators and Investigators

• Sponsor: Erchonia Corporation
• Investigators: Principal Investigator: Gregory C Roche, MD, FACS

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: non-invasive body contouring of waists hips and thighs
• Other Study ID Numbers: BCL-001