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The purpose of this study is to determine whether the application of green diode low level laser light therapy is effective in reducing the appearance of cellulite in the thighs and buttocks.
Cellulite is a common term used to describe superficial pockets of trapped fat, which causes uneven dimpling or "orange peel" skin. It appears in 90% of post-adolescent women. In advanced stages of cellulite, heaviness and pain may occur.
Currently available treatments for cellulite have minimal to no demonstrable effect and some involve risky invasive procedures. Therefore, the potential advantages of the application of low level laser light therapy to reduce the appearance of cellulite over current treatment options include a risk free procedure that is non-invasive and pain free. Since low level laser light within the green spectrum has been proven to increase the synthesis of collagen, it is believed that its application may serve to decrease the appearance of cellulite by tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of the connective tissue responsible for the formation of cellulite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia Scanner device (GLS) | Experimental | 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 | Sham Comparator | Inactive Erchonia GLS device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia Scanner device (GLS) | Device | The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Met the Individual Success Criteria | 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. | Baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bilateral Upper Thigh Circumference Measurement | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory C Roche, D.O. | Principal Investigator | |
| Robert F Jackson, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgeon's Inc. | Marion | Indiana | 46952 | United States | ||
| Bloomfield Laser and Cosmetic Surgery Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Device | Inactive Erchonia GLS device Placebo device: Inactive Erchonia GLS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects That Met the Individual Success Criteria | 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. | Posted | Number | participants | Baseline and 2 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert F. Jackson | Surgeon's Inc. | 765-662-8303 | rjlipodr@comteck.com |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo device | Device | Inactive Erchonia GLS. |
|
| Baseline and 2 weeks |
| Change in Body Weight | Body weight is measured in pounds (lbs) using a digital scale. | Baseline and 2 weeks |
| Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite. | 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. | Baseline and 2 weeks |
| Patient Satisfaction With Study Outcome | 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. | 2 Weeks |
| Bloomfield Hills |
| Michigan |
| 48302 |
| United States |
| Placebo Device |
Inactive Erchonia GLS device Placebo device: Inactive Erchonia GLS. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stage on the Nurnberger-Muller Scale (NMS) | 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. | Number | participants |
|
| Circumference measurement | 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. | Mean | Standard Deviation | inches |
|
| Body Mass Index (BMI) | Measured as kilograms per meter squared (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Percent Total Body Surface Area (TBSA) | 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. | Mean | Standard Deviation | percentage of TBSA |
|
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. |
| OG001 | Placebo Device | Inactive Erchonia GLS device Placebo device: Inactive Erchonia GLS. |
|
|
|
| Secondary | Bilateral Upper Thigh Circumference Measurement | 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. | Posted | Mean | Standard Deviation | inches | Baseline and 2 weeks |
|
|
|
|
| Secondary | Change in Body Weight | Body weight is measured in pounds (lbs) using a digital scale. | Posted | Mean | Standard Deviation | pounds | Baseline and 2 weeks |
|
|
|
|
| Secondary | Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite. | 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. | 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. | Posted | Mean | Standard Deviation | percentage of TBSA | Baseline and 2 weeks |
|
|
|
|
| Secondary | Patient Satisfaction With Study Outcome | 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. | Posted | Number | participants | 2 Weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Placebo Device | Inactive Erchonia GLS device Placebo device: Inactive Erchonia GLS. | 0 | 34 | 0 | 34 |
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