Status:
UNKNOWN
A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement
Lead Sponsor:
Samyang Biopharmaceuticals Corporation
Conditions:
Nasolabial Folds
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06093321
Start Date
November 13 2023
End Date
February 28 2025
Last Update
May 17 2024
Active Locations (1)
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1
Kyung Hee University Hospital
Seoul, South Korea