Needle Radiofrequency Treatment for Submental Fat

August 24, 2022 updated by: Jung-Won Shin, Seoul National University Bundang Hospital

Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat

The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale

Exclusion Criteria:

  • mental impairment, infectious disease
  • history of keloid development
  • pregnancy, pacemaker
  • use of anticoagulants
  • undergoing a facelift procedure within the prior 6 months.

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: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Post-treatment
After a single treatment using a microinsulated needle RF device
Procedure: microinsulated needle radiofrequency
A single treatment using a microinsulated needle radiofrequency device
NO_INTERVENTION: Pre-treatment (Baseline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
Time Frame: 1 month after the treatment
submental fat rating by an independent investigator
1 month after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
submental fat volume (cc)
Time Frame: 1 month after the treatment
fat volume quantified with a three-dimensional camera
1 month after the treatment
patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)
Time Frame: 1 month after the treatment
patient's satisfaction score for reduction of submental fat
1 month after the treatment
any adverse effects at any time during or after treatment
Time Frame: assessed through study completion, an average of 2 months
adverse events
assessed through study completion, an average of 2 months

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Chang-Hun Huh, Seoul National University Bundang Hospital

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 (ACTUAL)

June 7, 2021

Primary Completion (ACTUAL)

November 1, 2021

Study Completion (ACTUAL)

November 4, 2021

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (ACTUAL)

August 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • B-2012-655-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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