Nasolabial Folds
Conditions
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.
Interventions
DEVICESYB 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.
DEVICEMINT 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.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of participants with a minimum 1-point improvement in WSRS scores, as evaluated by independent rater 3 months after device application. | 3months | 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. |
Countries
South Korea
Contacts
Primary ContactGyeongsoon Kim
Outcome results
None listed