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

NCT02167867 | Completed Results

• 1 other identifier: EC_Z6_OTC
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Circumference Reduction

Keywords

body contouring; circumference reduction; body shaping; low level laser

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Baseline and 2 weeks

Study Arms (2)

Lay End Users

EXPERIMENTAL

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.

Device: Treatment Subject Group

Treatment Subject Group

EXPERIMENTAL

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.

Device: Lay End Users

Interventions

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

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.

Lay End Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to read and write English.
• Employees of the study test sites
• Treatment Subjects
• years of age or older
• Body Mass Index (BMI) \<= 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Lifetime Fitness

Colorado Springs, Colorado, 80920, United States

Location

Results Point of Contact

• Title: Elvira Walls, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Joseph Zapolsky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 27, 2024
• Results First Posted: July 1, 2016

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)