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

NCT01376037 | Completed Results

• 1 other identifier: EC_ARMBC
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Body Contouring

Keywords

upper arm; body contouring; body shaping

Outcome Measures

Primary Outcomes (1)

• Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint

  Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).

  baseline and 2 weeks

Study Arms (2)

inactive placebo laser device

PLACEBO COMPARATOR

The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.

Device: inactive placebo laser device

Erchonia ML Scanner (MLS)

ACTIVE COMPARATOR

The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter. Six procedures are administered evenly across 2 weeks.

Device: Erchonia(r) ML Scanner (MLS)

Interventions

Erchonia(r) ML Scanner (MLS) DEVICE

The Erchonia ML Scanner (MLS) low level laser light therapy device is administered to both arms for 20 minutes each, 6 times across 2 weeks.

Erchonia ML Scanner (MLS)

inactive placebo laser device DEVICE

non-therapeutic light application

inactive placebo laser device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Results Point of Contact

• Title: Mark S. Nestor, M.D., Ph.D
• Organization: Center for Clinical and Cosmetic Research

nestormd@ADMCORP.com

305-933-6716

Study Officials

• Mark S Nestor, M.D.,Ph.D.

  PRINCIPAL INVESTIGATOR

• Shari Sanchez, M.D.

  unaffilliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 30, 2014
• Results First Posted: May 29, 2013

Record last verified: 2014-05