Clinical trial NCT00738426: Study of Low Level Laser Therapy for Body Contouring
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Contouring
Keywords: non-invasive body contouring of waists hips and thighs
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Beach Gardens
country: United States
facility: Douglas D. Dedo, MD, FACS
state: Florida
city: Marion
country: United States
facility: Cosmetic Surgery
state: Indiana
city: Bloomfield Hills
country: United States
facility: Dr. Gregory C. Roche
state: Michigan
Study officials:
name: Gregory C Roche, MD, FACS
role: PRINCIPAL_INVESTIGATOR
name: Robert F Jackson, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: