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This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA IDF II | Experimental |
| |
| Perlane | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HA IDF II | Device | Treatment with HA IDF II (YVOIRE volume) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device. | Wrinkle Severity Rating Scale (WSRS)
| Week 26 (Visit 7) |
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Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 27, 2018 | |
| Reset | Mar 15, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 27, 2018 | Mar 15, 2019 |
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| Perlane |
| Device |
Treatment with Perlane |
|