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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.

Primary Purpose

Cellulite

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia Scanner device (GLS)
Placebo device
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks
  • Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area
  • PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System
  • Willing and able to abstain from partaking in any treatment other than the study procedure to promote cellulite appearance reduction/body contouring/weight loss during the study
  • Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study
  • Willing and able to maintain regular medication schedule, as is medically feasible, during the study

Exclusion Criteria:

  • Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks
  • P3 or P4 or P5 or P6 on the ASA Physical Status Classification System
  • Weight fluctuation greater than 10 pounds in the prior month
  • Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months
  • Prior surgical intervention to the treatment areas, for any reason
  • Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss
  • Current use of medication(s) known to affect weight levels and/or cause bloating or swelling and for which abstinence during the study is not safe or medically prudent
  • Any medical condition known to affect weight levels, cause bloating or swelling
  • Diagnosis of, and/or taking medication for, irritable bowel syndrome
  • Active infection, wound or other external trauma to the study treatment areas
  • Dermatitis or significant scarring in the study treatment areas
  • Medical, physical, or other contraindications for, or known sensitivity to, light therapy
  • Diabetes dependent on insulin or oral hypoglycemic medications
  • Known cardiovascular disease
  • Cardiac surgeries
  • History of deep venous thrombosis, arterial disease of the legs
  • Pregnant, breast feeding, or planning pregnancy prior to study end
  • Serious mental health illness or psychiatric hospitalization in past 2 years
  • Developmental disability or cognitive impairment that would impact study participation
  • Involved in litigation/receiving disability benefits related to the parameters of the study
  • Participation in research in the past 30 days

Sites / Locations

  • Surgeon's Inc.
  • Bloomfield Laser and Cosmetic Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Erchonia Scanner device (GLS)

Placebo device

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Body Weight
Body weight is measured in pounds (lbs) using a digital scale.
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.
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.

Full Information

First Posted
October 4, 2012
Last Updated
November 8, 2015
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01702259
Brief Title
Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
Official Title
A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Reducing the Appearance of Cellulite Clinical Study Protocol.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erchonia Scanner device (GLS)
Arm Type
Experimental
Arm Description
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
Arm Title
Placebo device
Arm Type
Sham Comparator
Arm Description
Inactive Erchonia GLS device
Intervention Type
Device
Intervention Name(s)
Erchonia Scanner device (GLS)
Intervention Description
The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
Intervention Type
Device
Intervention Name(s)
Placebo device
Intervention Description
Inactive Erchonia GLS.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Title
Change in Body Weight
Description
Body weight is measured in pounds (lbs) using a digital scale.
Time Frame
Baseline and 2 weeks
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
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System Willing and able to abstain from partaking in any treatment other than the study procedure to promote cellulite appearance reduction/body contouring/weight loss during the study Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study Willing and able to maintain regular medication schedule, as is medically feasible, during the study Exclusion Criteria: Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks P3 or P4 or P5 or P6 on the ASA Physical Status Classification System Weight fluctuation greater than 10 pounds in the prior month Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months Prior surgical intervention to the treatment areas, for any reason Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss Current use of medication(s) known to affect weight levels and/or cause bloating or swelling and for which abstinence during the study is not safe or medically prudent Any medical condition known to affect weight levels, cause bloating or swelling Diagnosis of, and/or taking medication for, irritable bowel syndrome Active infection, wound or other external trauma to the study treatment areas Dermatitis or significant scarring in the study treatment areas Medical, physical, or other contraindications for, or known sensitivity to, light therapy Diabetes dependent on insulin or oral hypoglycemic medications Known cardiovascular disease Cardiac surgeries History of deep venous thrombosis, arterial disease of the legs Pregnant, breast feeding, or planning pregnancy prior to study end Serious mental health illness or psychiatric hospitalization in past 2 years Developmental disability or cognitive impairment that would impact study participation Involved in litigation/receiving disability benefits related to the parameters of the study Participation in research in the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory C Roche, D.O.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert F Jackson, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgeon's Inc.
City
Marion
State/Province
Indiana
ZIP/Postal Code
46952
Country
United States
Facility Name
Bloomfield Laser and Cosmetic Surgery Center
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States

12. IPD Sharing Statement

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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.

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