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

Samyang Biopharmaceuticals Corporation

Status: Enrolling

Conditions: Nasolabial Folds

Treatments: Device: MINT lift®; Device: SYB PDO Thread

Study type: Interventional

Funder types: Industry

Identifiers

NCT06093321

CR_PDO_301

Details and patient eligibility

About

The objective of this clinical trial is to verify the safety and efficacy of SYB PDO Thread in the temporary improvement of nasolabial Folds.

Enrollment: 55 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

SYB PDO Thread

Experimental group

Description:

PDO Thread

Treatment:

Device: SYB PDO Thread

MINT lift®

Active Comparator group

Description:

PDO Thread

Treatment:

Device: MINT lift®