Reduction of Localized Excess Fat
Conditions
Keywords
Cellulite, Adipose tissue, Circumference, Reduction, Thigh
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.
Interventions
Up to three treatments, one pass, dosage range of 15-60 kJ.
Sponsors
Cutera Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Subject Satisfaction | Baseline and 6 months post final treatment |
| Adverse Events | At each visit (treatment and follow-up) or until resolution of AEs |
Countries
United States
Participant flow
Recruitment details
The study subjects were recruited in the medical clinic 01/30/09 through 04/07/09.
Participants by arm
| Arm | Count |
|---|---|
| Treated And Untreated Thigh Treated and untreated arms (left and right thighs) on the same subject. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Treated And Untreated Thigh |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 43 years STANDARD_DEVIATION 10.98 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated and Untreated Upper Thigh | Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms | 0.63 cm | Standard Deviation 1.2 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated and Untreated Upper Thigh | Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms | 1.0 cm | Standard Deviation 1.7 |
Secondary
Adverse Events
Time frame: At each visit (treatment and follow-up) or until resolution of AEs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated and Untreated Upper Thigh | Adverse Events | Sensitivity | 3 Event |
| Treated and Untreated Upper Thigh | Adverse Events | Erythema | 2 Event |
| Treated and Untreated Upper Thigh | Adverse Events | Edema | 2 Event |
| Treated and Untreated Upper Thigh | Adverse Events | Bruising | 2 Event |
| Treated and Untreated Upper Thigh | Adverse Events | Lumps | 3 Event |
| Treated and Untreated Upper Thigh | Adverse Events | Discomfort | 3 Event |
Secondary
Subject Satisfaction
Time frame: Baseline and 6 months post final treatment
Population: Data was not collected due to termination.