N/A
Completed N=72
Study of Low Level Laser Therapy for Body Contouring
Body Contouring
Source: ClinicalTrials.gov NCT00738426 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. — 21; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. |
21; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00738426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.