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| ID | Type | Description | Link |
|---|---|---|---|
| DMEDVINCI001 | Other Identifier | D. Med |
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| Name | Class |
|---|---|
| Chung-Ang University Hospital | OTHER |
| Seoul National University Hospital | OTHER |
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This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VINCI Plus | Experimental | One side has been treated with VINCI Plus |
|
| Restylane-L | Active Comparator | One side has been treated with Restylane-L |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VINCI Plus | Device | VINCI Plus 1ml injected into wrinkle treatment area |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) Evaluation | Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) Evaluation | Wrinkle Severity Rating Scale (WSRS) Evaluation at 2 weeks, and 6 weeks. | At 2 weeks, 6 weeks |
| Global Aesthetic Improvement Scale (GAIS) Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seongnam-si | Gyeonggi-do | South Korea | |||
| Chung-Ang University Hospital |
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| Restylane-L |
| Device |
Restylane-L injected into wrinkle treatment area |
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Global Aesthetic Improvement Scale (GAIS) Evaluation at 2 weeks, 6 weeks and 12 weeks.
| At 2 weeks, 6 weeks and 12 weeks |
| VAS pain assessment at each time point | VAS pain assessment at each time point (at injection and 15, 30, 45, and 60 min after injection) | at injection and 15, 30, 45, and 60 min after injection |
| Seoul |
| South Korea |