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

NCT06093321 | Unknown

• 1 other identifier: CR_PDO_301
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SYB PDO Thread

EXPERIMENTAL

PDO Thread

Device: SYB PDO Thread

MINT lift®

ACTIVE COMPARATOR

PDO Thread

Device: MINT lift®

Interventions

SYB PDO Thread DEVICE

Apply the test device (SYB PDO Thread) and the control device (MINT lift®) with 7±1 lines on each side of the nasolabial fold.

SYB PDO Thread

MINT lift® DEVICE

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®

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Jun Park, M.D.,Ph.D.

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gyeongsoon Kim

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 13, 2023
• Primary Completion: May 31, 2024
• Study Completion: February 28, 2025
• Last Updated: May 17, 2024

Record last verified: 2023-10

Locations

KR (1)