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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167867
Recruitment Status : Completed
First Posted : June 19, 2014
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Circumference Reduction
Interventions Device: Lay End Users
Device: Treatment Subject Group
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lay End Users Treatment Subject Group
Hide Arm/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 a Treatment Subject. Subjects who received active treatments with the study device administered by the Lay End Users.
Period Title: Overall Study
Started 22 22
Completed 22 22
Not Completed 0 0
Arm/Group Title Lay End Users Treatment Subject Group Total
Hide Arm/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 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. Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
20
  90.9%
19
  86.4%
39
  88.6%
Male
2
   9.1%
3
  13.6%
5
  11.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
20
  90.9%
22
 100.0%
42
  95.5%
More than one race
2
   9.1%
0
   0.0%
2
   4.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22 22 44
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 22 participants 22 participants 44 participants
NA [1]   (NA) 152.75  (25.59) NA [2]   (NA)
[1]
Measure of weight was not recorded to Lay End Users as it is not relevant to this group
[2]
Measure of weight was not recorded to Lay End Users as it is not relevant to this group; therefore, average values cannot be calculated.
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 22 participants 22 participants 44 participants
NA [1]   (NA) 24.68  (2.06) NA [2]   (NA)
[1]
Body Mass Index was not measures for Lay End Users as the measure is not relevant to this group.
[2]
Body Mass Index was not measures for Lay End Users as the measure is not relevant to this group; therefore average values cannot be calculated.
1.Primary Outcome
Title Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments
Hide Description The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lay End Users
Hide Arm/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.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
22
2.Primary Outcome
Title Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.
Hide Description The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated
Time Frame two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lay End Users
Hide Arm/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.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
22
3.Primary Outcome
Title Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6
Hide Description 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.
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Subject Group
Hide Arm/Group Description:
Individuals who got the active treatments with the ZERONA Z6.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: inches
-3.72  (2.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Subject Group
Comments t=+7.76
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ZERONA Z6
Hide Arm/Group Description

ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks.

ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs.

All-Cause Mortality
ZERONA Z6
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
ZERONA Z6
Affected / at Risk (%)
Total   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ZERONA Z6
Affected / at Risk (%)
Total   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elvira Walls, Clinical Consultant
Organization: Regulatory Insight, Inc.
Phone: 615-712-9743
EMail: elvira@reginsight.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT02167867    
Other Study ID Numbers: EC_Z6_OTC
First Submitted: June 17, 2014
First Posted: June 19, 2014
Results First Submitted: December 31, 2015
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016