Circumference Reduction
Conditions
Keywords
body contouring, circumference reduction, body shaping, low level laser
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.
Detailed 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.
Interventions
DEVICELay 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.
DEVICETreatment 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.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments | 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. | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Lay End Users | Treatment Subject Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Body Mass Index (BMI) | NA kg/m2 | 24.68 kg/m2 STANDARD_DEVIATION 2.06 | NA kg/m2 |
| Body Weight | NA pounds | 152.75 pounds STANDARD_DEVIATION 25.59 | NA pounds |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 22 Participants | 42 Participants |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 20 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
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.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lay End Users | Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6 | -3.72 inches | Standard Deviation 2.25 |
Comparison: t=+7.76p-value: <0.0001t-test, 2 sided
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lay End Users | Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments | 22 participants |
Primary
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
Time frame: two weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lay End Users | Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions. | 22 participants |