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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYB PDO Thread | Experimental | PDO Thread |
|
| MINT lift® | Active Comparator | PDO Thread |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gyeongsoon Kim | Contact | +82-2-2157-9851 | gyeongsoon.kim@samyang.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Park, M.D.,Ph.D. | Kyung Hee University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
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A Randomized, Subject-Independent Rater blinding, Paired Matching, Active-Controlled, Single Institution, Non-Inferiority Pivotal Trials
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| 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. |
|