Study of Low Level Laser Therapy for Body Contouring

• ClinicalTrials.gov Identifier: NCT00738426
• Recruitment Status: Completed
• First Posted: August 20, 2008
• Results First Posted: May 2, 2014
• Last Update Posted: February 10, 2020
• Sponsor: Erchonia Corporation
• Information provided by (Responsible Party): Erchonia Corporation

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Body Contouring	Device: Erchonia ML Scanner (MLS); Device: Sham device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: October 2007
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. [ Time Frame: 2 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Douglas D. Dedo, MD, FACS

Palm Beach Gardens, Florida, United States, 33410

United States, Indiana

Cosmetic Surgery

Marion, Indiana, United States, 46952

United States, Michigan

Dr. Gregory C. Roche

Bloomfield Hills, Michigan, United States, 48302

Sponsors and Collaborators

Erchonia Corporation

Investigators

• Principal Investigator: Gregory C Roche, MD, FACS
• Principal Investigator: Robert F Jackson, MD, FACS

More Information

• Responsible Party: Erchonia Corporation
• ClinicalTrials.gov Identifier: NCT00738426
• Other Study ID Numbers: BCL-001
• First Posted: August 20, 2008
• Results First Posted: May 2, 2014
• Last Update Posted: February 10, 2020
• Last Verified: January 2020

Keywords provided by Erchonia Corporation:

non-invasive body contouring of waists hips and thighs