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

Erchonia

Status: Completed

Conditions: Circumference Reduction

Treatments: Device: Treatment Subject Group; Device: Lay End Users

Study type: Interventional

Funder types: Industry

Identifiers

NCT02167867

EC_Z6_OTC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Lay End Users

Experimental group

Description:

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.

Treatment:

Device: Treatment Subject Group

Treatment Subject Group

Experimental group

Description:

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.

Treatment:

Device: Lay End Users