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

NCT01702259 | Completed Results

• 1 other identifier: EMCTE002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Bilateral Upper Thigh Circumference Measurement

  Baseline and 2 weeks

• Change in Body Weight

  Baseline and 2 weeks

• Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.

  Baseline and 2 weeks

• Patient Satisfaction With Study Outcome

  2 Weeks

Study Arms (2)

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.

Device: Erchonia Scanner device (GLS)

Placebo device

SHAM COMPARATOR

Inactive Erchonia GLS device

Device: Placebo device

Interventions

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.

Erchonia Scanner device (GLS)

Placebo device DEVICE

Inactive Erchonia GLS.

Placebo device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Surgeon's Inc.

Marion, Indiana, 46952, United States

Location

Bloomfield Laser and Cosmetic Surgery Center

Bloomfield Hills, Michigan, 48302, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Robert F. Jackson
• Organization: Surgeon's Inc.

rjlipodr@comteck.com

765-662-8303

Study Officials

• Gregory C Roche, D.O.

  PRINCIPAL INVESTIGATOR

• Robert F Jackson, M.D.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 8, 2012
• Study Start: October 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

US (2)