Thigh Circumference Reduction Study

Not Applicable

Terminated

Brief Summary: The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

Detailed Description: The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Recruitment & Eligibility

Inclusion Criteria

Body Mass Index between 20 and 35
Presence of cellulite grades II, III or IV according to GLD scale
Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper
Subject must be able to read, understand and sign the Consent Form
Subject must adhere to the follow-up schedule and study instructions
Subject must adhere to the same diet and/or exercise routine throughout the study

Exclusion Criteria

Significant weight fluctuation (+/-10 lbs) in the past 6 months
Taking weight-loss medications/supplements
Participation in any other clinical study
Cellulite treatment within 3 months of the treatment
Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
Prior treatment to the target area within the last 12 months
Arteriosclerosis or weakened blood vessels
Heart disease
Thromboembolic disease
Diagnosed or documented immune system disorders
Bleeding disorders.
Presence of uncontrolled hypertension
Taking prescription anticoagulants
History of keloid formation
Malignant tumors in the target area
Diabetes
Any disease or condition that could impair wound healing
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars
Infection in the target area
Implanted electrical device(s)
Pregnant or lactating

Arm && Interventions

Group	Intervention	Description
Treated Thigh	Cutera Radio Frequency Device	The thigh treated with the RF device

Primary Outcome Measures

Name	Time	Method
Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms	Baseline and 6 months post final treatment	Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms	Baseline and 6 months post final treatment	Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]

Secondary Outcome Measures