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

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093321
• Other study ID #: CR_PDO_301
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: October 2023
• Source: Samyang Biopharmaceuticals Corporation
• Contact: Gyeongsoon Kim
• Phone: +82-2-2157-9851
• Email: gyeongsoon.kim[@]samyang.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: February 28, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application.	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