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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

NCT ID: NCT02167867

Last Updated: 2024-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Circumference Reduction

Keywords

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body contouring circumference reduction body shaping low level laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Treatment Subject Group

Intervention Type 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.

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) laser diodes.

Group Type EXPERIMENTAL

Lay End Users

Intervention Type 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.

Interventions

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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.

Intervention Type 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) laser diodes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Treatment Subjects


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erchonia Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Zapolsky

Role: PRINCIPAL_INVESTIGATOR

Locations

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Lifetime Fitness

Colorado Springs, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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EC_Z6_OTC

Identifier Type: -

Identifier Source: org_study_id