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A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE volume plus | Experimental | Hyaluronic acid dermal filler |
|
| Restylane Lyft with Lidocaine | Active Comparator | Hyaluronic acid dermal filler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE volume plus | Device | Hyaluronic acid dermal filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine | To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment | 24 weeks from baseline |
| Responder rate of YVOIRE volume plus | To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment | 24 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS) | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS | 4, 8, 12, 52 weeks from baseline |
| Responder rate of YVOIRE volume plus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Investigator | LG Chem Investigational site 01 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG Chem investigational site 01 | Munich | Germany |
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| Restylane Lyft with Lidocaine |
| Device |
Hyaluronic acid dermal filler |
|
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
| 4, 8, 12, 52 weeks from baseline |
| Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS) | o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS | 4, 8, 12, 24, 52 weeks from baseline |
| The mean scores of the GAIS | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS) | 4, 8, 12, 24, 52 weeks from baseline |
| Mean change in mid-face volume | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement | 24 weeks from baseline |