Nasolabial FoldsNCT06093321
A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement
A study testing SYB PDO Thread and MINT lift® in people with Nasolabial Folds, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
The objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- SYB PDO Thread and MINT lift®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2023to 28 Feb 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those desiring temporary improvement of central facial nasolabial folds and having a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4.
- Individuals willing to discontinue all dermatological procedures or treatments, including wrinkle improvement in the central facial nasolabial fold, throughout the duration of this clinical trial.
Who cannot join
- Individuals who need to take anticoagulants from 2 weeks before the application of the clinical trial medical device to 2 weeks after (low-dose aspirin 100mg, maximum 300mg/day, is allowed).
- Those who need to take Vitamin E supplements, NSAIDs, or collagen supplements from 1 week before the application of the clinical trial medical device to 1 week after.
- Individuals with a history of bleeding disorders, either past or present.
- Those who have received treatments such as deep chemical peels, skin rejuvenation procedures, plastic surgery (including Botox injections), wrinkle improvement, or acne scar treatment on the face within 24 weeks from the screening date.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul
Jun Park, M.D.,Ph.D.
About this study
Official title: A Randomized, Blinded, Active-Controlled, Matched Pairs, Single-Institution, Non-Inferiority Trial to Compare and Evaluate the Efficacy and Safety of SYB PDO Thread and MINT Lift® for Temporarily Improvement of Nasolabial Folds
The objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds.
- Conditions
- Nasolabial Folds
- Being tested
- SYB PDO Thread, MINT lift®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYB PDO ThreadDevice
Apply the test device (SYB PDO Thread) and the control device (MINT lift®) with 7±1 lines on each side of the nasolabial fold.
MINT lift®Device
Apply the test device (SYB PDO Thread) and the control device (MINT lift®) with 7±1 lines on each side of the nasolabial fold.
| Study group | Role | What they receive |
|---|---|---|
| SYB PDO Thread | Experimental | PDO Thread Receives: Device: SYB PDO Thread |
| MINT lift® | Active comparator | PDO Thread Receives: Device: MINT lift® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start13 Nov 2023
- Primary completion31 May 2024 (estimated)
- Study completion28 Feb 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
- Model description
- A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Park, M.D.,Ph.D., Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093321
- Sponsor's protocol ID
- CR_PDO_301
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Active-Controlled, Matched Pairs, Single-Institution, Non-Inferiority Trial to Compare and Evaluate the Efficacy and Safety of SYB PDO Thread and MINT Lift® for Temporarily Improvement of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06093321
- Acronym / sponsor ID
- CR_PDO_301
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 23 Oct 2023 (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 objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials
| Arm | Type | Receives |
|---|---|---|
| SYB PDO Thread | Experimental | Device: SYB PDO ThreadPDO Thread |
| MINT lift® | Active comparator | Device: MINT lift®PDO Thread |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those desiring temporary improvement of central facial nasolabial folds and having a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4.
- Individuals willing to discontinue all dermatological procedures or treatments, including wrinkle improvement in the central facial nasolabial fold, throughout the duration of this clinical trial.
Key exclusion criteria (4 listed)
- Individuals who need to take anticoagulants from 2 weeks before the application of the clinical trial medical device to 2 weeks after (low-dose aspirin 100mg, maximum 300mg/day, is allowed).
- Those who need to take Vitamin E supplements, NSAIDs, or collagen supplements from 1 week before the application of the clinical trial medical device to 1 week after.
- Individuals with a history of bleeding disorders, either past or present.
- Those who have received treatments such as deep chemical peels, skin rejuvenation procedures, plastic surgery (including Botox injections), wrinkle improvement, or acne scar treatment on the face within 24 weeks from the screening date.
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 |
|---|---|---|
| SYB PDO ThreadApply the test device (SYB PDO Thread) and the control device (MINT lift®) with 7±1 lines on each side of the nasolabial fold. | Device | SYB PDO Thread |
| MINT lift®Apply the test device (SYB PDO Thread) and the control device (MINT lift®) with 7±1 lines on each side of the nasolabial fold. | Device | MINT lift® |
Primary outcome
The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.
Time frame: 3months
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Jun Park, M.D.,Ph.D. principal investigator
Kyung Hee University 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 SYB PDO Thread and MINT lift® in people with Nasolabial Folds, run by Samyang Biopharmaceuticals Corporation 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 2 inclusion and 4 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 17 May 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 Gyeongsoon Kim (+82-2-2157-9851, gyeongsoon.kim@samyang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application. (time frame: 3months). 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 17 May 2024.