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Sponsor's decision
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The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE Y-Solution 360 | Experimental | Maximum 5 ml including touch-up |
|
| No-treatment | No Intervention | No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE Y-Solution 360 | Device | Hyaluronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded | 5-grade photonumeric hand grading scale (grade 0 - grade 4) | 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator | 5-grade photonumeric hand grading scale (grade 0 - grade 4) | Up to 52 weeks after treatment |
| ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University | Bucheon-si | Gyeonggi-do | South Korea | |||
| Eulji Hospital |
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5-point scale rating global aesthetic improvement in appearance (score -1 - score 3) |
| Up to 52 weeks after treatment |
| Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator | 5-grade photonumeric hand grading scale (grade 0 - grade 4) | Up to 52 weeks after treatment |
| Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject | 5-point scale rating global aesthetic improvement in appearance (score -1 - score 3) | Up to 52 weeks after treatment |
| Safety profile as assessed by incidence of adverse events | Up to 52 weeks after treatment |
| Seoul |
| South Korea |