Needle Radiofrequency Treatment for Submental Fat

NCT ID: NCT05517824

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2021-11-04

Brief Summary

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

Detailed Description

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Conditions

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Obese

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

prospective, single-blinded, pre-post comparative study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Post-treatment

After a single treatment using a microinsulated needle RF device

Group Type ACTIVE_COMPARATOR

microinsulated needle radiofrequency

Intervention Type PROCEDURE

A single treatment using a microinsulated needle radiofrequency device

Pre-treatment (Baseline)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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microinsulated needle radiofrequency

A single treatment using a microinsulated needle radiofrequency device

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang-Hun Huh

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

References

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Kim BR, Kim M, Kim JW, Shin JW, Na JI, Huh CH. Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat. Dermatol Surg. 2023 Apr 1;49(4):389-394. doi: 10.1097/DSS.0000000000003723. Epub 2023 Feb 10.

Reference Type DERIVED
PMID: 36799883 (View on PubMed)

Other Identifiers

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B-2012-655-001

Identifier Type: -

Identifier Source: org_study_id

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