Cellulite
Conditions
Keywords
Cellulite, Adipose tissue, Circumference, Reduction, Thigh, Abdomen, Flank
Brief summary
The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.
Detailed description
The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm. At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Female or Male * Minimum age of 18 years * Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study. * Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only) * Minimum Body Mass Index of 20 * Visible fat in the area to be treated Area to be treated to measure at least 20.0mm 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, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)
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, large moles * Infection in the target area * Implanted electrical device(s) * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Circumference (cm) | Baseline and 6 months post final treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | Baseline and 6 months post final treatment | — |
| The Number of Participants With Adverse Events | Up to 6 months after the last treatment | 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 01/01/09 through 01/13/10.
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency (RF) Treatment Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ) | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 23 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Radiofrequency (RF) Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Change in Circumference (cm)
Time frame: Baseline and 6 months post final treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiofrequency (RF) Treatment | Change in Circumference (cm) | Thigh | 0.6 Centimeters (cm) | Standard Deviation 4.7 |
| Radiofrequency (RF) Treatment | Change in Circumference (cm) | Abdomen | -0.5 Centimeters (cm) | Standard Deviation 2.2 |
| Radiofrequency (RF) Treatment | Change in Circumference (cm) | Flank | -1.4 Centimeters (cm) | Standard Deviation 2.1 |
Secondary
Subject Satisfaction
Time frame: Baseline and 6 months post final treatment
Secondary
The Number of Participants With Adverse Events
At each visit (treatment and follow-up) or until resolution of AEs
Time frame: Up to 6 months after the last treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiofrequency (RF) Treatment | The Number of Participants With Adverse Events | Edema | 1 Participants |
| Radiofrequency (RF) Treatment | The Number of Participants With Adverse Events | Lumps | 3 Participants |