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

Last updated: May 15, 2024
Sponsor: Samyang Biopharmaceuticals Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

SYB PDO Thread

MINT lift®

Clinical Study ID

NCT06093321
CR_PDO_301
  • Ages 19-70
  • All Genders

Study 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

Inclusion Criteria:

  1. Those desiring temporary improvement of central facial nasolabial folds and having aWrinkle 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 theduration of this clinical trial.

Exclusion

Exclusion Criteria:

  1. Individuals who need to take anticoagulants from 2 weeks before the application ofthe 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 1week 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 rejuvenationprocedures, plastic surgery (including Botox injections), wrinkle improvement, oracne scar treatment on the face within 24 weeks from the screening date.

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: SYB PDO Thread
Phase:
Study Start date:
November 13, 2023
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Kyung Hee University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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