Study of Low Level Laser Therapy for Body Contouring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00738426
First received: August 18, 2008
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Body Contouring
Device: Erchonia ML Scanner (MLS)
Device: Sham device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Erchonia Corporation:

Primary Outcome Measures:
  • Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738426

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

No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00738426     History of Changes
Other Study ID Numbers: BCL-001
Study First Received: August 18, 2008
Results First Received: February 25, 2014
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Erchonia Corporation:
non-invasive body contouring of waists hips and thighs

ClinicalTrials.gov processed this record on July 22, 2014