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A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE Classic plus | Experimental |
| |
| Restylane Lidocaine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid dermal filler | Device | Hyaluronic acid dermal filler used for facial volume or wrinkle correction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24. | To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme). | 24 weeks from baseline |
| Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24. | To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated. | 24 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG Chem investigational site 01 | Darmstadt | Germany |
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