Thigh Circumference Reduction Study

Cutera Inc.4 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Reduction of Localized Excess Fat

Interventions

Cutera Radio Frequency DeviceDEVICE

Up to three treatments, one pass, dosage range of 15-60 kJ.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Blackhawk Plastic Surgery

Danville, California, United States

Outcomes

Primary Outcomes

Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms

Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]

Time frame: Baseline and 6 months post final treatment

Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms

Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]

Time frame: Baseline and 6 months post final treatment

Secondary Outcomes

Subject Satisfaction

Time frame: Baseline and 6 months post final treatment

Adverse Events

Time frame: At each visit (treatment and follow-up) or until resolution of AEs

Data from ClinicalTrials.gov

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