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

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

Official Title
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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

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: SYB PDO Thread
* Device: MINT lift®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 19 to 70 years. 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. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent in the subject consent form. Exclusion Criteria: 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. Individuals who have received treatments such as CaHA (Calcium Hydroxypatite), PLLA (Poly L-Lactide), Polycaprolactone (Poly-L-Lactide) on the application site of the clinical trial medical device within 1 year from the screening date, or HA (Hyaluronic acid), Polydioxanone within 24 weeks from the screening date, or have a history of PMMA (Polymethylmethacrylate) treatment regardless of the time frame. Those who have used local anesthetics (steroids, retinoids: for pharmaceuticals and cosmetics), or functional cosmetics for wrinkle improvement on the face within 4 weeks from the screening date or plan to use them during the clinical trial (steroid ointment can be used for up to 14 consecutive days for therapeutic purposes). Individuals who have used immunosuppressants, chemotherapy, or systemic corticosteroids within 12 weeks from the screening date. Individuals with facial skin conditions, wounds, infections, or scars that may affect the clinical trial. Those with autoimmune diseases or a history of such diseases, or individuals with compromised immune systems that may affect the clinical trial. Individuals with hypertrophic freckles or keloids on the face. Those with a history of anaphylaxis or severe complex allergies. Individuals with chronic or recurrent infectious or inflammatory diseases that may affect the clinical trial. Those with skin hypersensitivity to the components of the clinical trial medical device. Those who have experienced side effects with amide-based local anesthetics, EMLA Cream, or similar lidocaine preparations (excluding subjects not using EMLA Cream or similar lidocaine preparations). Individuals with confirmed sarcoidosis or Osler's endocarditis. Those with clinically significant disorders in the cardiovascular, digestive, respiratory, endocrine, or central nervous systems, or individuals with mental illnesses that have or currently have a significant impact on the clinical trial. Pregnant and breastfeeding women. Women of childbearing potential who do not agree to use medically approved contraception for up to 12 weeks after the application of the clinical trial medical device. Individuals who have received clinical trial drugs or clinical trial medical devices in other clinical trials within 4 weeks from the screening date. Others deemed by the clinical trial investigator to make the conduct of this clinical trial difficult.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 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 |