Study of Low Level Laser Therapy for Body Contouring

Completed · Not applicable · Has a placebo group

Conditions studied: Body Contouring

In brief

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.

Key facts

Study ID

NCT00738426

Run by

Erchonia Corporation

People needed

72

Starts

2007-10-01

Expected to finish

2008-07-01

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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