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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT01702259
First received: October 4, 2012
Last updated: November 8, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Cellulite
Device: Erchonia Scanner device (GLS)
Device: Placebo device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Further study details as provided by Erchonia Corporation:

Primary Outcome Measures:
  • Number of Subjects That Met the Individual Success Criteria [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Body weight is measured in pounds (lbs) using a digital scale.

  • Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite. [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 68
Study Start Date: October 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Sham Comparator: Placebo device
Inactive Erchonia GLS device
Device: Placebo device
Inactive Erchonia GLS.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702259

Locations
United States, Indiana
Surgeon's Inc.
Marion, Indiana, United States, 46952
United States, Michigan
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, United States, 48302
Sponsors and Collaborators
Erchonia Corporation
Investigators
Principal Investigator: Gregory C Roche, D.O.
Principal Investigator: Robert F Jackson, M.D.
  More Information

No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT01702259     History of Changes
Other Study ID Numbers: EMCTE002 
Study First Received: October 4, 2012
Results First Received: July 9, 2015
Last Updated: November 8, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 11, 2016