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

Not Applicable

Completed

• Conditions: Circumference Reduction

• Registration Number: NCT02167867
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-19
• Study Start: 2014-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-12-31
• Results First Submitted QC: 2016-05-24
• Results First Posted: 2016-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments	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.	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	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.

Trial Locations

Locations (1)

Lifetime Fitness; 🇺🇸 Colorado Springs, Colorado, United States