Clinical trial NCT01702259: Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Subjects That Met the Individual Success Criteria
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Bilateral Upper Thigh Circumference Measurement
timeFrame: Baseline and 2 weeks
measure: Change in Body Weight
timeFrame: Baseline and 2 weeks
measure: Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
timeFrame: Baseline and 2 weeks
measure: Patient Satisfaction With Study Outcome
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Marion
country: United States
facility: Surgeon's Inc.
state: Indiana
city: Bloomfield Hills
country: United States
facility: Bloomfield Laser and Cosmetic Surgery Center
state: Michigan
Study officials:
name: Gregory C Roche, D.O.
role: PRINCIPAL_INVESTIGATOR
name: Robert F Jackson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: