Needle Radiofrequency Treatment for Submental Fat

Seoul National University Bundang Hospital24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obese

Interventions

microinsulated needle radiofrequencyPROCEDURE

A single treatment using a microinsulated needle radiofrequency device

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Outcomes

Primary Outcomes

Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)

submental fat rating by an independent investigator

Time frame: 1 month after the treatment

Secondary Outcomes

submental fat volume (cc)

fat volume quantified with a three-dimensional camera

Time frame: 1 month after the treatment

patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)

patient's satisfaction score for reduction of submental fat

Time frame: 1 month after the treatment

any adverse effects at any time during or after treatment

adverse events

Time frame: assessed through study completion, an average of 2 months

Data from ClinicalTrials.gov

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