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: NA
Last verified: October 2012
History: No changes posted
  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:
  • Stage on the Nurnberger-Muller Scale (NMS). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The Nurnberger-Muller Scale (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.


Secondary Outcome Measures:
  • Bilateral Upper Thigh Circumference [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Circumference measurements of the right and left upper thighs recorded in inches.

  • Body Mass Index (BMI) [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    BMI is calculated as the ratio of a person's weight in kilograms (kgs) to his or her height in meters squared (m²).

  • % Body Surface Area covered by cellulite. [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    The % body surface area covered by cellulite will be marked and quantified according to the Lund and Browder Chart and methodology.

  • Stage on the Nurnberger-Muller Scale (NMS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Nurnberger-Muller Scale (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.


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 mW, 532 nanometer of green laser light.
Device: 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.
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 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 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
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
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014