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The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYB Filler (SF-01) | Experimental | PCL filler |
|
| Ellansé M | Active Comparator | PCL filler |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYB Filler (SF-01) | Device | Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed | 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. | 12months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beom Joon KIM, M.D.,Ph.D. | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea |
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A Randomized, Subject & Evaluator-blind, Matched pairs, Prospective Study
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| Ellansé M | Device | Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold. |
|