UnknownNot Applicable

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

South Korea55 participantsStarted 2023-11-13

Plain-language 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.

Who can participate

Age range19 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.

Timeframe: 3months

Trial details

NCT IDNCT06093321

SponsorSamyang Biopharmaceuticals Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-31

Contact for this trial

Gyeongsoon Kim

+82-2-2157-9851 gyeongsoon.kim@samyang.com

View on ClinicalTrials.gov More Nasolabial Folds trials