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This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE® contour | Experimental |
| |
| Restylane SubQ™ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE® contour | Device | YVOIRE® contour injection into the anteromedial malar region |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mid Face Aesthetic Scale (MFAS) score | Mean of MFAS score as assessed by the independent blinded rater | 26 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mid Face Aesthetic Scale (MFAS) score | Mean of MFAS score as assessed by the independent blinded rater | 2, 14, and 52 weeks after treatment |
| Mid Face Aesthetic Scale (MFAS) score | Changes of MFAS score as assessed by the independent blinded rater |
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Inclusion Criteria:
Be male or female, 20-65 years of age
Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
Desire filler treatment to correct volume loss in the anteromedial malar region
Accept the obligation not to receive any other mid facial procedures or treatments during the study
Signed informed consent
Those who fall under one of the following 3 cases
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 7, 2018 | |
| Reset | Mar 11, 2019 |
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| Restylane SubQ™ |
| Device |
Restylane SubQ™ injection into the anteromedial malar region |
|
| 2, 14, 26, and 52 weeks after treatment |
| Mid Face Aesthetic Scale (MFAS) Responder rate | MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater | 2, 14, 26, and 52 weeks after treatment |
| Global Aesthetic Improvement Scale (GAIS) score | Mean of GAIS score as assessed by subject | 2, 14, 26, and 52 weeks after treatment |
| Global Aesthetic Improvement Scale (GAIS) Responder rate | GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject | 2, 14, 26, and 52 weeks after treatment |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 7, 2018 | Mar 11, 2019 |