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Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.

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: NCT01702259
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cellulite
Interventions Device: Erchonia Scanner device (GLS)
Device: Placebo device
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Period Title: Overall Study
Started 34 34
Completed 34 34
Not Completed 0 0
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device Total
Hide Arm/Group Description

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Total of all reporting groups
Overall Number of Baseline Participants 34 34 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 34 participants 68 participants
39.87  (10.08) 39.94  (10.72) 39.91  (10.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 68 participants
Female
34
 100.0%
34
 100.0%
68
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 68 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
1
   2.9%
1
   2.9%
2
   2.9%
White
31
  91.2%
31
  91.2%
62
  91.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.9%
2
   5.9%
4
   5.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 34 participants 68 participants
34 34 68
Stage on the Nurnberger-Muller Scale (NMS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 68 participants
Stage II 19 18 37
Stage III 15 16 31
[1]
Measure Description: The Nurnberger-Muller Scale (NMS) is a four-stage scale to classify stage or degree of cellulite. Stage II is defined as dimpling appearing spontaneously when standing but not when lying down. Orange peel appearance of the skin is evident to the naked eye without need for manipulation. Stage III is defined as dimpling spontaneously present with standing and lying down, evident to the naked eye without manipulation. Orange peel skin surface appearance with raised areas and nodules. NMS is assessed for both legs of each participant, and the worse of the stages is reported.
Circumference measurement   [1] 
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 34 participants 34 participants 68 participants
47.09  (3.65) 46.05  (4.66) 46.55  (3.92)
[1]
Measure Description: Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure at standardized measurement points. Results are reported as combined bilateral (right+left thigh) circumference measurements.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 34 participants 34 participants 68 participants
25.42  (2.84) 24.98  (2.77) 25.22  (2.80)
[1]
Measure Description: Measured as kilograms per meter squared (kg/m2)
Percent Total Body Surface Area (TBSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of TBSA
Number Analyzed 34 participants 34 participants 68 participants
15.52  (6.06) 14.38  (7.01) 14.87  (6.54)
[1]
Measure Description: 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.
1.Primary Outcome
Title Number of Subjects That Met the Individual Success Criteria
Hide Description 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.
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description:

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Overall Number of Participants Analyzed 34 34
Measure Type: Number
Unit of Measure: participants
19 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia Scanner Device (GLS), Placebo Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Bilateral Upper Thigh Circumference Measurement
Hide Description Circumference 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.
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description:

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: inches
-0.85  (1.01) -0.39  (0.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia Scanner Device (GLS), Placebo Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Body Weight
Hide Description Body weight is measured in pounds (lbs) using a digital scale.
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description:

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: pounds
-1.41  (1.62) -0.31  (1.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia Scanner Device (GLS), Placebo Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
Hide Description 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.
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description:

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Overall Number of Participants Analyzed 23 29
Mean (Standard Deviation)
Unit of Measure: percentage of TBSA
-3.89  (1.45) -0.66  (0.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia Scanner Device (GLS), Placebo Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Patient Satisfaction With Study Outcome
Hide Description

At 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.

Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description:

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

Overall Number of Participants Analyzed 29 31
Measure Type: Number
Unit of Measure: participants
18 8
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia Scanner Device (GLS) Placebo Device
Hide Arm/Group Description

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.

Inactive Erchonia GLS device

Placebo device: Inactive Erchonia GLS.

All-Cause Mortality
Erchonia Scanner Device (GLS) Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Erchonia Scanner Device (GLS) Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia Scanner Device (GLS) Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (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: Dr. Robert F. Jackson
Organization: Surgeon's Inc.
Phone: 765-662-8303
EMail: rjlipodr@comteck.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT01702259    
Other Study ID Numbers: EMCTE002
First Submitted: October 4, 2012
First Posted: October 8, 2012
Results First Submitted: July 9, 2015
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015