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

Erchonia Corporation44 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Circumference Reduction

Interventions

Lay End UsersDEVICE

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.

Treatment Subject GroupDEVICE

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) laser diodes.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lifetime Fitness

Colorado Springs, Colorado, United States

Outcomes

Primary Outcomes

Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments

The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.

Time frame: Baseline

Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.

The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated

Time frame: two weeks

Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6

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.

Time frame: Baseline and 2 weeks

Data from ClinicalTrials.gov

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