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Completed

NCT Number: NCT02167867

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

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.

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Key information

Conditions

Circumference Reduction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lifetime Fitness

Colorado Springs, Colorado, 80920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lay End Users

Device

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 Group

Device

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2014
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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