Trial Outcomes & Findings for Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals (NCT NCT01821352)
NCT ID: NCT01821352
Last Updated: 2015-12-11
Results Overview
Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.
COMPLETED
NA
53 participants
Baseline and 4 Weeks
2015-12-11
Participant Flow
Participant milestones
| Measure |
Erchonia Obesity Laser
The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW) 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
|
Placebo Laser
Placebo Laser device emits sham green light that has no therapeutic effect.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
Baseline characteristics by cohort
| Measure |
Erchonia Obesity Laser
n=28 Participants
The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
|
Placebo Laser
n=25 Participants
Placebo Laser device emitting sham green light that has no therapeutic effect.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.32 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
47.84 years
STANDARD_DEVIATION 9.30 • n=7 Participants
|
47.04 years
STANDARD_DEVIATION 10.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Total Circumference Measurement
|
123.35 inches
STANDARD_DEVIATION 10.29 • n=5 Participants
|
122.81 inches
STANDARD_DEVIATION 11.85 • n=7 Participants
|
123.04 inches
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Body Mass Index (BMI)
|
34.58 kg/m2
STANDARD_DEVIATION 3.06 • n=5 Participants
|
33.60 kg/m2
STANDARD_DEVIATION 2.98 • n=7 Participants
|
34.04 kg/m2
STANDARD_DEVIATION 3.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 WeeksIndividual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.
Outcome measures
| Measure |
Erchonia Obesity Laser
n=28 Participants
The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
|
Placebo Laser
n=25 Participants
Placebo Laser device emitting sham green light that has no therapeutic effect.
|
|---|---|---|
|
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements
|
20 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline and 4 WeeksIndividual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total combined body circumference measurement. Change in combined circumference measurement is calculated as the difference in circumference measurements from baseline to endpoint (4 weeks). A negative (-) change indicates a decrease in circumference and is positive for study success. A positive (+) change indicates an increase in circumference and is negative for study success.
Outcome measures
| Measure |
Erchonia Obesity Laser
n=28 Participants
The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
|
Placebo Laser
n=25 Participants
Placebo Laser device emitting sham green light that has no therapeutic effect.
|
|---|---|---|
|
Change in Combined Circumference Measurement
|
-4.14 inches
Standard Deviation 2.99
|
-0.71 inches
Standard Deviation 1.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 WeeksSubjects rated satisfaction with the outcome of the study procedures with respect to change in body shape on the following 5-point scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Not Very Satisfied, Not at All Satisfied. Results are reported as the number of subjects in each treatment group who rated study outcome satisfaction as 'Very Satisfied' or 'Somewhat Satisfied'.
Outcome measures
| Measure |
Erchonia Obesity Laser
n=28 Participants
The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
|
Placebo Laser
n=25 Participants
Placebo Laser device emitting sham green light that has no therapeutic effect.
|
|---|---|---|
|
Subject Satisfaction With Procedure Outcome
|
22 participants
|
4 participants
|
Adverse Events
Erchonia Obesity Laser
Placebo Laser
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place