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The primary objective of the study is to demonstrate non-inferiority of VP1 Lido US versus an approved hyaluronic acid dermal filler following deep (subdermal and/or supraperiosteal) injection of the cheek for volume augmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VP1 Lido US - NC | Experimental | Injection to the left cheek via needle and to the right cheek via canula |
|
| VP1 Lido US - CN | Experimental | Injection to the left cheek via canula and to the right cheek via needle |
|
| Restylane Lyft Lidocaine - NC | Active Comparator | Injection to the left cheek via needle and to the right cheek via canula |
|
| Restylane Lyft Lidocaine - CN | Active Comparator | Injection to the left cheek via canula and to the right cheek via needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VP1 Lido US | Device | Hyaluronic acid dermal filler containing lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS) | The MCFAS is a 5-point ordinal rating | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle) | Baseline to week 12 | |
| Treatment response rate where response is defined as a ≥ 1-point improvement on both cheeks when comparing the change from baseline to Week 12 | Baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hautmedizin Bad Soden, Merz Investigational Site #0490189 | Bad Soden am Taunus | 65812 | Germany | |||
| Rosenparkklinik, Merz Investigational Site #0490099 |
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| Restylane Lyft Lidocaine | Device | Hyaluronic acid dermal filler containing lidocaine |
|
| FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12 | Week 12 |
| Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator | Week 12 |
| GAIS scores for treated subjects at Week 12, as completed by the subject | Week 12 |
| Responder rates at Week 12, according to the MCFAS, as assessed by three blinded board-certified Independent Panel Reviewers (IPRs) using subject photographs | Week 12 |
| Incidence of related serious or delayed onset adverse events (>21 days after treatment) following the first treatment including touch-up until Week 48 | Baseline to week 48 |
| Darmstadt |
| 64297 |
| Germany |
| Praxis für Hautkrankheiten, Merz Investigational Site #0490375 | Drensteinfurt | 48317 | Germany |
| Dermatologic Private Practive, Merz Investigational Site #0490381 | Düsseldorf | 40212 | Germany |
| Universität Hamburg, Merz Investigational Site #0490095 | Hamburg | 20146 | Germany |
| Dermatologic Private Practice, Merz Investigational Site #0490345 | Hamburg | 22609 | Germany |
| Private Clinic, Merz Investigational Site #0490284 | Mannheim | 68161 | Germany |
| Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371 | München | 80539 | Germany |
| Haut- und Lasercentrum Potsdam, Merz Investigational Site #0490362 | Potsdam | 14467 | Germany |
| Centroderm GmbH, Merz Investigational Site #0490367 | Wuppertal | 42287 | Germany |