N/A
N=62
Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference
Body Contouring
Bottom Line
View on ClinicalTrials.gov: NCT01376037 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint — 18; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia(r) ML Scanner (MLS) (Device); inactive placebo laser device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint |
18; 1 | — |
Summary
The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light laser device can help to reduce the circumference of the upper arms.
Eligibility Criteria
Inclusion Criteria
- 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; specifically for the indication of body contouring of the bilateral upper arms (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 Liposuction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS)), and/or for the procedure of brachioplasty (upper arm lift).
- Body Mass Index (BMI) of 20 to 35 kg/m².
- Subject is willing and able to abstain from partaking in any treatment other than the study procedure to promote body contouring and/or weight loss during study participation.
- Subject is willing and able to maintain his or her regular (typical pre-study procedure) diet and exercise regimen without effecting significant change in either direction during study participation.
Exclusion Criteria
- Subject is seeking upper arm body contouring as a means of weight loss.
- Diabetes dependent on insulin or oral hypoglycemic medications.
- Known cardiovascular disease such as cardiac arrhythmias, congestive heart failure.
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical intervention for body sculpting of the arms, such as liposuction or brachioplasty.
- Prior surgical intervention for weight loss, such as stomach stapling, lap band surgery.
- 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.
- Any medical condition known to affect weight levels and/or to cause bloating or swelling.
- Mastectomy or operations in the axilla lymph nodes.
- Active infection, wound or other external trauma to the areas to be treated with the laser.
- Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- Serious mental health illness such as Alzheimer's, schizophrenia and bipolar disorder; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that in the professional judgment of the study Principal Investigator (PI) would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
- Photosensitivity disorder.
- Active or recurrent cancer or currently receiving chemotherapy or radiation therapy.
- Involvement in litigation/worker's compensation claim/receiving disability benefits related to weight-related and/or body shape issues.
- Participation in any type of research in the past 30 days.
Data sourced from ClinicalTrials.gov (NCT01376037). 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.