Clinical trial NCT00953290: Thigh Circumference Reduction Study
Official title: Cutera Radio Frequency Device for Thigh Circumference Reduction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reduction of Localized Excess Fat
Keywords: Cellulite
Adipose tissue
Circumference
Reduction
Thigh
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
timeFrame: Baseline and 6 months post final treatment
measure: Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms
timeFrame: Baseline and 6 months post final treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: Baseline and 6 months post final treatment
measure: Adverse Events
timeFrame: At each visit (treatment and follow-up) or until resolution of AEs
Other outcomes:
Locations:
city: Danville
country: United States
facility: Blackhawk Plastic Surgery
state: California
Study officials:
name: Stephen J. Ronan, MD
role: PRINCIPAL_INVESTIGATOR
name: Jacqueline Calkin, MD
role: PRINCIPAL_INVESTIGATOR
name: Christine Lee, MD
role: PRINCIPAL_INVESTIGATOR
name: Scott Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References: