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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

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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

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.

Condition or disease Intervention/treatment Phase
Circumference Reduction Device: Lay End Users Device: Treatment Subject Group Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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.
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.
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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167867


Locations
United States, Colorado
Lifetime Fitness
Colorado Springs, Colorado, United States, 80920
Sponsors and Collaborators
Erchonia Corporation
Investigators
Principal Investigator: Joseph Zapolsky

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT02167867     History of Changes
Other Study ID Numbers: EC_Z6_OTC
First Posted: June 19, 2014    Key Record Dates
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Erchonia Corporation:
body contouring
circumference reduction
body shaping
low level laser