Trial Outcomes & Findings for Study of Low Level Laser Light Therapy on Circumference Reduction (NCT NCT02109107)
NCT ID: NCT02109107
Last Updated: 2016-02-02
Results Overview
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
COMPLETED
NA
54 participants
Baseline and 6 weeks
2016-02-02
Participant Flow
Participant milestones
| Measure |
Erchonia® Zerona 6 Headed Scanner (EZ6) Laser
The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
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|---|---|
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Overall Study
STARTED
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54
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Overall Study
COMPLETED
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52
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Erchonia® Zerona 6 Headed Scanner (EZ6) Laser
The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
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|---|---|
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Overall Study
Lost to Follow-up
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2
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Baseline Characteristics
Study of Low Level Laser Light Therapy on Circumference Reduction
Baseline characteristics by cohort
| Measure |
Erchonia EZ6 Laser
n=54 Participants
The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
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|---|---|
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Age, Continuous
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46.39 years
STANDARD_DEVIATION 9.83 • n=99 Participants
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Sex: Female, Male
Female
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51 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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4 Participants
n=99 Participants
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Race (NIH/OMB)
White
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49 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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54 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksCombined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
Outcome measures
| Measure |
Erchonia EZ6 Laser
n=54 Participants
The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
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|---|---|
|
Change in Combined Circumference Measurements
|
-5.36 inches
Standard Deviation 1.85
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SECONDARY outcome
Timeframe: Baseline and 6 weeksBody weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.
Outcome measures
| Measure |
Erchonia EZ6 Laser
n=54 Participants
The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
|
|---|---|
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Change in Body Weight
|
-1.40 pounds
Standard Deviation 0.85
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SECONDARY outcome
Timeframe: Baseline and 6 weeksBody mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.
Outcome measures
| Measure |
Erchonia EZ6 Laser
n=54 Participants
The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
|
|---|---|
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Change in Body Mass Index (BMI)
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-0.28 kg/m2
Standard Deviation 0.11
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SECONDARY outcome
Timeframe: 6 weeksAt the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?", using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied
Outcome measures
| Measure |
Erchonia EZ6 Laser
n=52 Participants
The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
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|---|---|
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Subject Satisfaction With Study Outcome Rating
Very Satisfied
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28 participants
|
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Subject Satisfaction With Study Outcome Rating
Somewhat Satisfied
|
14 participants
|
|
Subject Satisfaction With Study Outcome Rating
Neither Satisfied Nor Dissatisfied
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4 participants
|
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Subject Satisfaction With Study Outcome Rating
Not Very Satisfied
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3 participants
|
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Subject Satisfaction With Study Outcome Rating
Not At All Satisfied
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3 participants
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Adverse Events
Erchonia EZ6 Laser
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elvira Walls, Clinical Consultant
Regulatory Insight, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place