Trial Outcomes & Findings for Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks. (NCT NCT01702259)
NCT ID: NCT01702259
Last Updated: 2015-12-11
Results Overview
The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
COMPLETED
NA
68 participants
Baseline and 2 weeks
2015-12-11
Participant Flow
Participant milestones
| Measure |
Erchonia Scanner Device (GLS)
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
|
Placebo Device
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
Baseline characteristics by cohort
| Measure |
Erchonia Scanner Device (GLS)
n=34 Participants
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
|
Placebo Device
n=34 Participants
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.87 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
39.94 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
39.91 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Stage on the Nurnberger-Muller Scale (NMS)
Stage II
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Stage on the Nurnberger-Muller Scale (NMS)
Stage III
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Circumference measurement
|
47.09 inches
STANDARD_DEVIATION 3.65 • n=5 Participants
|
46.05 inches
STANDARD_DEVIATION 4.66 • n=7 Participants
|
46.55 inches
STANDARD_DEVIATION 3.92 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.42 kg/m2
STANDARD_DEVIATION 2.84 • n=5 Participants
|
24.98 kg/m2
STANDARD_DEVIATION 2.77 • n=7 Participants
|
25.22 kg/m2
STANDARD_DEVIATION 2.80 • n=5 Participants
|
|
Percent Total Body Surface Area (TBSA)
|
15.52 percentage of TBSA
STANDARD_DEVIATION 6.06 • n=5 Participants
|
14.38 percentage of TBSA
STANDARD_DEVIATION 7.01 • n=7 Participants
|
14.87 percentage of TBSA
STANDARD_DEVIATION 6.54 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksThe individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
Outcome measures
| Measure |
Erchonia Scanner Device (GLS)
n=34 Participants
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
|
Placebo Device
n=34 Participants
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
|---|---|---|
|
Number of Subjects That Met the Individual Success Criteria
|
19 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksCircumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.
Outcome measures
| Measure |
Erchonia Scanner Device (GLS)
n=34 Participants
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
|
Placebo Device
n=34 Participants
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
|---|---|---|
|
Bilateral Upper Thigh Circumference Measurement
|
-0.85 inches
Standard Deviation 1.01
|
-0.39 inches
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksBody weight is measured in pounds (lbs) using a digital scale.
Outcome measures
| Measure |
Erchonia Scanner Device (GLS)
n=34 Participants
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
|
Placebo Device
n=34 Participants
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
|---|---|---|
|
Change in Body Weight
|
-1.41 pounds
Standard Deviation 1.62
|
-0.31 pounds
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.
The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.
Outcome measures
| Measure |
Erchonia Scanner Device (GLS)
n=23 Participants
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
|
Placebo Device
n=29 Participants
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
|---|---|---|
|
Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
|
-3.89 percentage of TBSA
Standard Deviation 1.45
|
-0.66 percentage of TBSA
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 2 WeeksAt completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-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 who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.
Outcome measures
| Measure |
Erchonia Scanner Device (GLS)
n=29 Participants
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.
|
Placebo Device
n=31 Participants
Inactive Erchonia GLS device
Placebo device: Inactive Erchonia GLS.
|
|---|---|---|
|
Patient Satisfaction With Study Outcome
|
18 participants
|
8 participants
|
Adverse Events
Erchonia Scanner Device (GLS)
Placebo Device
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