ObeseNCT05517824
Needle Radiofrequency Treatment for Submental Fat
A study testing microinsulated needle radiofrequency in people with Obese, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- microinsulated needle radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2021to 4 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale
Who cannot join
- mental impairment, infectious disease
- history of keloid development
- pregnancy, pacemaker
- use of anticoagulants
- undergoing a facelift procedure within the prior 6 months.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: 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.
- Conditions
- Obese
- Being tested
- microinsulated needle radiofrequency
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microinsulated needle radiofrequencyProcedure or surgery
A single treatment using a microinsulated needle radiofrequency device
| Study group | Role | What they receive |
|---|---|---|
| Post-treatment | Active comparator | After a single treatment using a microinsulated needle RF device Receives: Procedure: microinsulated needle radiofrequency |
| Pre-treatment (Baseline) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
submental fat rating by an independent investigator
Measured: 1 month after the treatment
Secondary outcomes (3)
submental fat volume (cc)
fat volume quantified with a three-dimensional camera
Measured: 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
Measured: 1 month after the treatment
any adverse effects at any time during or after treatment
adverse events
Measured: assessed through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start7 Jun 2021
- Primary completion1 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- prospective, single-blinded, pre-post comparative study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Shin, Seoul National University Bundang Hospital
- Investigators
- Chang-Hun Huh, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517824
- Sponsor's protocol ID
- B-2012-655-001
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36799883
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat
- ClinicalTrials.gov ID
- NCT05517824
- Acronym / sponsor ID
- B-2012-655-001
- Conditions
- Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, single-blinded, pre-post comparative study
| Arm | Type | Receives |
|---|---|---|
| Post-treatment | Active comparator | Procedure: microinsulated needle radiofrequencyAfter a single treatment using a microinsulated needle RF device |
| Pre-treatment (Baseline) | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale
Key exclusion criteria (5 listed)
- mental impairment, infectious disease
- history of keloid development
- pregnancy, pacemaker
- use of anticoagulants
- undergoing a facelift procedure within the prior 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microinsulated needle radiofrequencyA single treatment using a microinsulated needle radiofrequency device | Procedure or surgery | Post-treatment |
Primary outcome
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
3 secondary outcomes
submental fat volume (cc)
Time frame: 1 month after the treatment
patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 36799883Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Hun Huh principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microinsulated needle radiofrequency in people with Obese, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe) (time frame: 1 month after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.