A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement

Launched by SAMYANG BIOPHARMACEUTICALS CORPORATION · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SYB PDO Thread to see how safe and effective it is for improving nasolabial folds, which are the lines that run from the sides of your nose to the corners of your mouth. If you have these folds and would like to see temporary improvement, you might be eligible to participate. Eligible participants are typically adults who have a moderate to severe appearance of these folds and are willing to stop any other skin treatments during the trial.

If you decide to join the study, you will receive the SYB PDO Thread treatment and be monitored for its effects. It's important to note that certain medications, like blood thinners and some supplements, will need to be avoided before and after the treatment. Additionally, if you've had certain cosmetic procedures in the last six months, you may not be able to participate. Overall, this trial aims to help find effective ways to reduce the appearance of nasolabial folds, and your involvement could contribute to important findings in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Those desiring temporary improvement of central facial nasolabial folds and having a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4.
• • 2. 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 Criteria:
• • 1. 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).
• • 2. 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.
• • 3. Individuals with a history of bleeding disorders, either past or present.
• • 4. 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.