Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Kangbuk Samsung Hospital21 enrolled

Overview

To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Subcutaneous Fat

Interventions

Noninvasive Radiofrequency TruSculptPROCEDURE

Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline in thickness of the submental fat at 6 months

thickness of the submental fat measured by ultrasound

Time frame: 6 months

Change from Baseline in submental circumference at 6 months

thickness of the submental fat measured by a tape measure

Time frame: 6 months

Secondary Outcomes

participants' assessment for improvement at 6 months

assessment for improvement by participants

Time frame: 6 months

participants' assessment for satisfaction at 6 months

assessment for satisfaction by participants

Time frame: 6 months

Data from ClinicalTrials.gov

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