Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring

Not Applicable

Completed

• Conditions: Subcutaneous Fat
• Interventions: Procedure: Noninvasive Radiofrequency TruSculpt

• Registration Number: NCT02512822
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2015-01
• Status Verified: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-30
• Last Update Submitted: 2015-07-30
• Study First Posted: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Noninvasive Radiofrequency TruSculpt	Noninvasive Radiofrequency

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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