Study of Low Level Laser Light Therapy on Circumference Reduction

NCT02109107 | Completed Results

• 1 other identifier: EC_EZ6_BC_001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Circumference Reduction

Keywords

body contouring; body shaping; circumference reduction

Outcome Measures

Primary Outcomes (1)

• Change in Combined Circumference Measurements

  Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.

  Baseline and 6 weeks

Secondary Outcomes (3)

• Change in Body Weight

  Baseline and 6 weeks

• Change in Body Mass Index (BMI)

  Baseline and 6 weeks

• Subject Satisfaction With Study Outcome Rating

  6 weeks

Study Arms (1)

Erchonia EZ6 Laser

EXPERIMENTAL

The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Device: Erchonia EZ6 Laser

Interventions

Erchonia EZ6 Laser DEVICE

The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Also known as: Erchonia® Zerona 6 Headed Scanner

Erchonia EZ6 Laser

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Advanced Gynecology Specialists of Augusta, LLC

Evans, Georgia, 30809, United States

Location

CT Dermatology PC

Fruitland, Idaho, 83619, United States

Location

Related Publications (1)

• Thornfeldt CR, Thaxton PM, Hornfeldt CS. A Six-week Low-level Laser Therapy Protocol is Effective for Reducing Waist, Hip, Thigh, and Upper Abdomen Circumference. J Clin Aesthet Dermatol. 2016 Jun;9(6):31-5. Epub 2016 Jun 1.

  PMID: 27386049 DERIVED

Results Point of Contact

• Title: Elvira Walls, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Carl R Thornfeldt, MD

  PRINCIPAL INVESTIGATOR

• Paul M Thaxton, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 2, 2016
• Results First Posted: February 2, 2016

Record last verified: 2015-12

Locations

US (2)