N/A
N=54
Study of Low Level Laser Light Therapy on Circumference Reduction
Circumference Reduction
Bottom Line
View on ClinicalTrials.gov: NCT02109107 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Combined Circumference Measurements — -5.36 inches — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia EZ6 Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Combined Circumference Measurements |
-5.36 | <.0001 sig |
| SECONDARY Change in Body Weight |
-1.40 | <0.05 sig |
| SECONDARY Change in Body Mass Index (BMI) |
-0.28 | <0.005 sig |
| SECONDARY Subject Satisfaction With Study Outcome Rating |
28; 14; 4; 3; 3 | — |
Summary
The purpose of this study is to determine whether low level laser light therapy is effective in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) between 25 kg/m² and 40 kg/m²
- Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues that do not respond to diet and exercise for the hips, waist, thighs and upper abdomen. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society of Lipo-Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS))
- Willing and able to abstain from treatments other than the study procedure for body contouring/circumference reduction/weight loss during study participation
- Willing and able to maintain typical diet and exercise regimen during study participation
Exclusion Criteria
- Body Mass Index (BMI) less than 25 kg/m² or greater than 40 kg/m²
- Known cardiovascular disease
- Cardiac surgeries such as bypass, heart transplant surgery, pacemakers
- Prior surgical intervention for body sculpting/weight loss
- Medical, physical, or other contraindications for body sculpting/weight loss
- Current use of medication known to affect weight levels/cause bloating or swelling and for which abstinence during study participation is not possible
- Any medical condition known to affect weight levels and/or cause bloating or swelling.
- Diagnosis of, and/or taking medication for, irritable bowel syndrome.
- Active infection, wound or other external trauma to the study treatment areas
- Known photosensitivity disorder
- Active cancer or currently receiving treatment for cancer
- Pregnant or planning pregnancy prior to study participation end
- Serious mental health illness such as dementia/schizophrenia; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that may preclude adequate comprehension of the consent form and/or ability to record the study measures
- Involvement in litigation/worker's compensation/disability benefits related to the study parameters
- Participation in clinical research in the past 30 days
Data sourced from ClinicalTrials.gov (NCT02109107). 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.