Abdominal Fat
Conditions
Brief summary
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
Detailed description
The objectives of this study are to evaluate efficacy and safety of treatment with the Cutera truSculpt RF device for circumferential reduction in the abdominal and flank region.
Interventions
DEVICEtruSculpt rf device
radiofrequency device
Sponsors
Cutera Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
24 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Female or Male, 24 to 60 years of age (inclusive). Fitzpatrick Skin Type I - VI. Has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region Has a Body Mass Index (BMI) ≥ 20 and ≤ 30 Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study. Subject must agree to not undergo any other procedure(s) in the abdominal and flank region during the study period. Subject must be able to read, understand and sign the Informed 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 5% of baseline weight measurement. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.
Exclusion criteria
* Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period. Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments. Any prior invasive cosmetic surgery to the target area, such as liposuction. Currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant. Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders. Diagnosed or documented immune system disorders. History of any disease or condition that could impair wound healing. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing. Infection, dermatitis, rash or other skin abnormality in the target area. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation. Pregnant or currently breastfeeding. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment | 12 weeks | Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | 12 weeks | Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals no change and 4 equals Very Significant Improvement. |
| Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | 12 weeks | Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals very dissatisfied and 5 equals very satisfied. |
| Subject Discomfort and Pain Levels During Treatment | 12 weeks | Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals No pain and 10 equals Worst possible pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment truSculpt rf device, therapeutic settings
truSculpt rf device: radiofrequency device | 47 |
| Sham truSculpt rf device, non-therapeutic settings
truSculpt rf device: radiofrequency device | 23 |
| Total | 70 |
Baseline characteristics
| Characteristic | Treatment | Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 23 Participants | 70 Participants |
| Sex: Female, Male Female | 37 Participants | 8 Participants | 45 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 47 / 47 | 23 / 23 |
| serious Total, serious adverse events | 0 / 47 | 0 / 23 |
Outcome results
Primary
Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment
Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment | 1.9 cm | Standard Error 0.1 |
| Sham | Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment | 0 cm | Standard Error 0.1 |
Secondary
Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals no change and 4 equals Very Significant Improvement.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | 2.4 units on a scale | Standard Deviation 1 |
| Sham | Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | 1 units on a scale | Standard Deviation 1.5 |
Secondary
Subject Discomfort and Pain Levels During Treatment
Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals No pain and 10 equals Worst possible pain.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Subject Discomfort and Pain Levels During Treatment | 5.75 units on a scale | Standard Deviation 0.9 |
| Sham | Subject Discomfort and Pain Levels During Treatment | 1.1 units on a scale | Standard Deviation 0.3 |
Secondary
Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.
Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals very dissatisfied and 5 equals very satisfied.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | 4.1 units on a scale | Standard Deviation 0.8 |
| Sham | Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment. | 3.3 units on a scale | Standard Deviation 0.9 |