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A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Hyaluronic acid dermal filler at Week 0 |
|
| Control group | No Intervention | Remain untreated until Week 26 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE Y-Solution 720 | Device | Hyaluronic acid dermal filler |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection | The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1). | 26 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | LG Chem Investigational site 01 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG Chem investigational site 01 | Vienna | Austria | ||||
| LG Chem investigational site 02 |
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| Vienna |
| Austria |
| LG Chem investigational site 03 | Krakow | Poland |