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Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167867
Recruitment Status : Completed
First Posted : June 19, 2014
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Tracking Information
First Submitted Date  ICMJE June 17, 2014
First Posted Date  ICMJE June 19, 2014
Results First Submitted Date  ICMJE December 31, 2015
Results First Posted Date  ICMJE July 1, 2016
Last Update Posted Date July 1, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments [ Time Frame: Baseline ]
    The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.
  • Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions. [ Time Frame: two weeks ]
    The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated
  • Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6 [ Time Frame: Baseline and 2 weeks ]
    Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs
Official Title  ICMJE Evaluation of Efficacy, Usability and Labeling Comprehension for Over-the-Counter Use of the Erchonia Corporation ZERONA® Z6 for Body Contouring of the Waist, Hips and Thighs
Brief Summary The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.
Detailed Description

The Erchonia ZERONA® Z6 is a low level laser light therapy device that has been approved by the United States Food and Drug Administration (FDA) for use by licensed medical professionals to help to reduce the circumference of the hips, waist and thighs.

This study is to see if the Erchonia ZERONA® Z6 can be used by lay (non-medical professional) people to treat others to help to reduce the circumference of the hips, waist and thighs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Circumference Reduction
Intervention  ICMJE
  • Device: Lay End Users
    Lay End Users administer 40 minutes of treatment with the ZERONA Z6 to the waist, hips and thighs (20 minutes to the front side and 20 minutes to the back side) of a Treatment Subject, 6 times evenly spaced across two consecutive weeks.
  • Device: Treatment Subject Group
    Treatment subject received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
Study Arms  ICMJE
  • Experimental: Lay End Users
    Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject.
    Intervention: Device: Treatment Subject Group
  • Experimental: Treatment Subject Group
    Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
    Intervention: Device: Lay End Users
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
44
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Lay End Users

Inclusion Criteria:

  • 18 years of age or older
  • Able to read and write English.
  • Employees of the study test sites

Treatment Subjects

Inclusion Criteria

  • 18 years of age or older
  • Body Mass Index (BMI) <= 30 kg/m2

Exclusion Criteria

  • Pregnancy
  • Open wounds (sores, cuts, ulcers, etc.) on or around the waist, hips and/or thighs
  • Currently have or are being treated for any cancerous growths on or around the waist, hips and/or thighs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02167867
Other Study ID Numbers  ICMJE EC_Z6_OTC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erchonia Corporation
Study Sponsor  ICMJE Erchonia Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Zapolsky
PRS Account Erchonia Corporation
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP