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

Completed · Not applicable · Has a placebo group

Conditions studied: Cellulite

In brief

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.

Key facts

Study ID

NCT01702259

Run by

Erchonia Corporation

People needed

68

Starts

2009-10-01

Expected to finish

2012-09-01

Last updated by the study team

2015-12-11

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

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
• 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

Where it is running

• Surgeon's Inc. — Marion, Indiana, United States
• Bloomfield Laser and Cosmetic Surgery Center — Bloomfield Hills, Michigan, United States

Full record on ClinicalTrials.gov

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