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

May 15, 2024 updated by: Samyang Biopharmaceuticals Corporation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
          • Jun Park, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYB PDO Thread
PDO Thread
Device: SYB PDO Thread
Apply the test device (SYB PDO Thread) and the control device (MINT lift®) with 7±1 lines on each side of the nasolabial fold.
Active Comparator: MINT lift®
PDO Thread
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samyang Biopharmaceuticals Corporation

Investigators

  • Principal Investigator: Jun Park, M.D.,Ph.D., Kyung Hee University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CR_PDO_301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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