Needle Radiofrequency Treatment for Submental Fat
Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat
1 other identifier
interventional
24
1 country
1
Brief Summary
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2021
CompletedFirst Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedAugust 26, 2022
August 1, 2022
5 months
August 23, 2022
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
submental fat rating by an independent investigator
1 month after the treatment
Secondary Outcomes (3)
submental fat volume (cc)
1 month after the treatment
patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)
1 month after the treatment
any adverse effects at any time during or after treatment
assessed through study completion, an average of 2 months
Study Arms (2)
Post-treatment
ACTIVE COMPARATORAfter a single treatment using a microinsulated needle RF device
Pre-treatment (Baseline)
NO INTERVENTIONInterventions
A single treatment using a microinsulated needle radiofrequency device
Eligibility Criteria
You may qualify if:
- Patients with excess submental fat on a grade of 1\~4, as assessed by the Physician-Assisted Submental Fat Rating Scale
You may not qualify if:
- mental impairment, infectious disease
- history of keloid development
- pregnancy, pacemaker
- use of anticoagulants
- undergoing a facelift procedure within the prior 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Related Publications (1)
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.
PMID: 36799883DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-Hun Huh
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 26, 2022
Study Start
June 7, 2021
Primary Completion
November 1, 2021
Study Completion
November 4, 2021
Last Updated
August 26, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share