Study of Over-The-Counter Use of Low Level Laser Light Therapy for Body Contouring of the Waist, Hips and Thighs
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|ClinicalTrials.gov Identifier: NCT02167867|
Recruitment Status : Completed
First Posted : June 19, 2014
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Circumference Reduction||Device: Lay End Users Device: Treatment Subject Group||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: 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.
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) light-emitting diodes.
Experimental: 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) light-emitting diodes.
Device: 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.
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167867
|United States, Colorado|
|Colorado Springs, Colorado, United States, 80920|
|Principal Investigator:||Joseph Zapolsky|