Nasolabial FoldsNCT06216418
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds
A study testing BRFS-18G-S100WH and MINT Lift FINE+ in people with Nasolabial Folds, run by Hugel at 1 site in South Korea.
Trial summary
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- BRFS-18G-S100WH and MINT Lift FINE+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Feb 2024to 30 Oct 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 19 years of age
- Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)
- Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing
Who cannot join
- A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.
- Those who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.
Read the detailed description
This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.
- Conditions
- Nasolabial Folds
- Being tested
- BRFS-18G-S100WH, MINT Lift FINE+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRFS-18G-S100WHDevice
A facial tissue fixation material made of polydioxanone (PDO).
MINT Lift FINE+Device
A facial tissue fixation material made of polydioxanone (PDO).
| Study group | Role | What they receive |
|---|---|---|
| BRFS-18G-S100WH | Experimental | Not described Receives: Device: BRFS-18G-S100WH |
| MINT Lift FINE+ | Active comparator | Not described Receives: Device: MINT Lift FINE+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate (%) at 12 weeks after the procedure compared to baseline.
Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.
Measured: Baseline to week 12
Secondary outcomes (3)
WSRS evaluation by an independent evaluator
Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.
Measured: Baseline to week 4, 8, 24
WSRS evaluation by tester
Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.
Measured: Baseline to week 4, 8, 24
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline by the subject
Measured: Baseline to week 4, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start29 Feb 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jworld
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216418
- Sponsor's protocol ID
- JWD-TH-01
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06216418
- Acronym / sponsor ID
- JWD-TH-01
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Collaborators
- Jworld
- Study start
- 29 Feb 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 22 Jan 2024 (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.
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.
Detailed description
This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRFS-18G-S100WH | Experimental | Device: BRFS-18G-S100WH |
| MINT Lift FINE+ | Active comparator | Device: MINT Lift FINE+ |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 19 years of age
- Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)
- Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing
Key exclusion criteria (2 listed)
- A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.
- Those who are pregnant or lactating
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 |
|---|---|---|
| BRFS-18G-S100WHA facial tissue fixation material made of polydioxanone (PDO). | Device | BRFS-18G-S100WH |
| MINT Lift FINE+A facial tissue fixation material made of polydioxanone (PDO). | Device | MINT Lift FINE+ |
Primary outcome
Improvement rate (%) at 12 weeks after the procedure compared to baseline.
Time frame: Baseline to week 12
Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.
3 secondary outcomes
WSRS evaluation by an independent evaluator
Time frame: Baseline to week 4, 8, 24
WSRS evaluation by tester
Time frame: Baseline to week 4, 8, 24
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.
Time frame: Baseline to week 4, 8, 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRFS-18G-S100WH and MINT Lift FINE+ in people with Nasolabial Folds, run by Hugel 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cho Long Park (+82-2-6966-1654, clpark@hugel.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate (%) at 12 weeks after the procedure compared to baseline. (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.