Comparing SYB PDO Thread and MINT Lift® for Nasolabial Fold Improvement
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
NA · Samyang Biopharmaceuticals Corporation · NCT06093321
This study is testing whether SYB PDO Thread or MINT Lift® works better to reduce wrinkles around the nose and mouth for people looking for cosmetic improvements.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Samyang Biopharmaceuticals Corporation (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06093321 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of SYB PDO Thread compared to MINT Lift® for the temporary improvement of nasolabial folds. Participants will be assessed based on their desire for facial wrinkle reduction and must meet specific criteria regarding their current treatments and health conditions. The study will involve administering these interventions and monitoring the outcomes related to wrinkle severity. The goal is to determine which method provides better results for patients seeking cosmetic enhancement.
Who should consider this trial
Good fit: Ideal candidates are individuals seeking temporary improvement of nasolabial folds with a moderate to severe wrinkle severity rating.
Not a fit: Patients with bleeding disorders or those currently using anticoagulants or certain supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer patients a more effective option for temporary facial wrinkle improvement.
How similar studies have performed: Other studies have shown promising results with similar cosmetic interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Kyung Hee University Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Jun Park, M.D.,Ph.D. — Kyung Hee University Hospital
- Study coordinator: Gyeongsoon Kim
- Email: gyeongsoon.kim@samyang.com
- Phone: +82-2-2157-9851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasolabial Folds