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This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of YVOIRE contour injected into the anteromedial malar region in subjects who have completed the LG-HACL014 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE contour | Experimental |
|
| 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 | 2, 26, and 52 weeks after repeat treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mid Face Aesthetic Scale (MFAS) score | Changes of MFAS score as assessed by the independent blinded rater | 2, 26, and 52 weeks after repeat treatment |
| Mid Face Aesthetic Scale (MFAS) Responder rate |
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Inclusion Criteria:
Eligible subjects who have completed the LG-HACL014 study
Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study
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 |
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MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater
| 2, 26, and 52 weeks after repeat treatment |
| Global Aesthetic Improvement Scale (GAIS) score | Mean of GAIS score as assessed by subject | 2, 26, and 52 weeks after repeat 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, 26, and 52 weeks after repeat treatment |