Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring (UNIRFFC)

July 30, 2015 updated by: Won-Serk Kim, Kangbuk Samsung Hospital
To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
Noninvasive Radiofrequency
Procedure: Noninvasive Radiofrequency TruSculpt
Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
Other Names:
  • TruSculpt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in thickness of the submental fat at 6 months
Time Frame: 6 months
thickness of the submental fat measured by ultrasound
6 months
Change from Baseline in submental circumference at 6 months
Time Frame: 6 months
thickness of the submental fat measured by a tape measure
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
participants' assessment for improvement at 6 months
Time Frame: 6 months
assessment for improvement by participants
6 months
participants' assessment for satisfaction at 6 months
Time Frame: 6 months
assessment for satisfaction by participants
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Collaborators

Cutera Inc.

Investigators

  • Study Director: Won-Serk Kim, M.D., Ph.D., Kangbuk Samsung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KBC13251D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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