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N/A N=62 Randomized Triple-blind Treatment

Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference

Body Contouring

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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