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

• 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: Erchonia Corporation
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Erchonia Scanner Device (GLS)	Placebo Device
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

Baseline Characteristics

Arm/Group Title		Erchonia Scanner Device (GLS)	Placebo Device	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Number of Subjects That Met the Individual Success Criteria
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia Scanner Device (GLS)	Placebo Device
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

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia Scanner Device (GLS)	Placebo Device
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)

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
Description	Body weight is measured in pounds (lbs) using a digital scale.
Time Frame	Baseline and 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia Scanner Device (GLS)	Placebo Device
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)

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.
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erchonia Scanner Device (GLS)	Placebo Device
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

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Erchonia Scanner Device (GLS)	Placebo Device
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	--/--	--/--
Serious Adverse Events
	Erchonia Scanner Device (GLS)	Placebo Device
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/34 (0.00%)	0/34 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr. Robert F. Jackson
• Organization: Surgeon's Inc.
• Phone: 765-662-8303
• EMail: rjlipodr@comteck.com

• 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