Subcutaneous Fat
Conditions
Keywords
radiofrequency, submental fat, fat reduction, body contouring
Brief summary
To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.
Detailed description
Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis. Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.
Interventions
PROCEDURENoninvasive Radiofrequency TruSculpt
Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
Sponsors
Cutera Inc.
Kangbuk Samsung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* clinically appreciable localized excess of subcutaneous fat on the submental area * no history of systemic underlying disease
Exclusion criteria
* any infectious or inflammatory skin diseases * keloids * psychiatric patients * systemic underlying disease * who had taken aesthetic procedure on the face, before 6-month * more than 5% weight change were dropped out.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in thickness of the submental fat at 6 months | 6 months | thickness of the submental fat measured by ultrasound |
| Change from Baseline in submental circumference at 6 months | 6 months | thickness of the submental fat measured by a tape measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| participants' assessment for improvement at 6 months | 6 months | assessment for improvement by participants |
| participants' assessment for satisfaction at 6 months | 6 months | assessment for satisfaction by participants |
Outcome results
None listed