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This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical examination or treatment. | Diagnostic Test | Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed-onset nodule. | Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected. | 1 year. |
| Other adverse events. | Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected. | 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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Any healthy male and female whose filler injection on facial area is already planned for volume enhancement and anti-wrinkle treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong Yeop Shin | Seoul | Gangseo-gu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38595129 | Derived | Park SJ, Yoo KH. One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study. Dermatol Surg. 2024 Aug 1;50(8):731-738. doi: 10.1097/DSS.0000000000004190. Epub 2024 May 2. |
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Incidence rate of delayed-onset nodule or other side effects when YVOIRE Y-Solution 360 or 540 or 720 are used.
The data is expected to be available during 2022.
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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