Subcutaneous FatUNIRFFCNCT02512822
Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring
A study testing Noninvasive Radiofrequency TruSculpt in people with Subcutaneous Fat, run by Kangbuk Samsung Hospital.
Trial summary
To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Fat
- What is being tested?
- Noninvasive Radiofrequency TruSculpt
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jul 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinically appreciable localized excess of subcutaneous fat on the submental area
- no history of systemic underlying disease
Who cannot join
- any infectious or inflammatory skin diseases
- keloids
- psychiatric patients
- systemic underlying disease
- who had taken aesthetic procedure on the face, before 6-month
- more than 5% weight change were dropped out.
About this study
To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.
Read the detailed description
Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis.
Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.
- Conditions
- Subcutaneous Fat
- Being tested
- Noninvasive Radiofrequency TruSculpt
- Keywords
- radiofrequency, submental fat, fat reduction, body contouring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Radiofrequency TruSculptProcedure or surgery
Also called TruSculpt
Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Noninvasive Radiofrequency Receives: Procedure: Noninvasive Radiofrequency TruSculpt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in thickness of the submental fat at 6 months
thickness of the submental fat measured by ultrasound
Measured: 6 months
Change from Baseline in submental circumference at 6 months
thickness of the submental fat measured by a tape measure
Measured: 6 months
Secondary outcomes (2)
participants' assessment for improvement at 6 months
assessment for improvement by participants
Measured: 6 months
participants' assessment for satisfaction at 6 months
assessment for satisfaction by participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subcutaneous FatStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cutera Inc.
- Responsible party
- Principal investigator, Won-Serk Kim, Kangbuk Samsung Hospital
- Investigators
- Won-Serk Kim, M.D., Ph.D., Study director, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512822
- Sponsor's protocol ID
- KBC13251D
- Acronym
- UNIRFFC
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franco W, Kothare A, Ronan SJ, Grekin RC, McCalmont TH. Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: feasibility studies. Lasers Surg Med. 2010 Jul;42(5):361-70. doi: 10.1002/lsm.20925.
PubMed 20583242Franco W, Kothare A, Goldberg DJ. Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology. Lasers Surg Med. 2009 Dec;41(10):745-50. doi: 10.1002/lsm.20876.
PubMed 20014265
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring
- ClinicalTrials.gov ID
- NCT02512822
- Acronym / sponsor ID
- UNIRFFC / KBC13251D
- Conditions
- Subcutaneous Fat
- Keywords
- radiofrequency, submental fat, fat reduction, body contouring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Collaborators
- Cutera Inc.
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.
Detailed description
Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis.
Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Procedure: Noninvasive Radiofrequency TruSculptNoninvasive Radiofrequency |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinically appreciable localized excess of subcutaneous fat on the submental area
- no history of systemic underlying disease
Key exclusion criteria (6 listed)
- any infectious or inflammatory skin diseases
- keloids
- psychiatric patients
- systemic underlying disease
- who had taken aesthetic procedure on the face, before 6-month
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 |
|---|---|---|
| Noninvasive Radiofrequency TruSculptAlso: TruSculptHeating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis. | Procedure or surgery | Participants |
Primary outcome
Change from Baseline in thickness of the submental fat at 6 months
Time frame: 6 months
thickness of the submental fat measured by ultrasound
Change from Baseline in submental circumference at 6 months
Time frame: 6 months
thickness of the submental fat measured by a tape measure
2 secondary outcomes
participants' assessment for improvement at 6 months
Time frame: 6 months
participants' assessment for satisfaction at 6 months
Time frame: 6 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 31 Jul 2015.
- Background: PubMed 20583242Franco W, Kothare A, Ronan SJ, Grekin RC, McCalmont TH. Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: feasibility studies. Lasers Surg Med. 2010 Jul;42(5):361-70. doi: 10.1002/lsm.20925.
- Background: PubMed 20014265Franco W, Kothare A, Goldberg DJ. Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology. Lasers Surg Med. 2009 Dec;41(10):745-50. doi: 10.1002/lsm.20876.
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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.
Won-Serk Kim, M.D., Ph.D. study director
Kangbuk Samsung Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Radiofrequency TruSculpt in people with Subcutaneous Fat, run by Kangbuk Samsung Hospital.
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 2 inclusion and 6 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline in thickness of the submental fat at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02512822, which also lists 2 linked publications.
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 31 Jul 2015.