Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
NCT ID: NCT01702259
Last Updated: 2015-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2009-10-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Placebo device
Inactive Erchonia GLS device
Placebo device
Inactive Erchonia GLS.
Interventions
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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.
Placebo device
Inactive Erchonia GLS.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
FEMALE
Yes
Sponsors
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Erchonia Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory C Roche, D.O.
Role: PRINCIPAL_INVESTIGATOR
Robert F Jackson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Locations
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Surgeon's Inc.
Marion, Indiana, United States
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, United States
Countries
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Other Identifiers
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EMCTE002
Identifier Type: -
Identifier Source: org_study_id