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The purpose of this study is to evaluate the perception of facial expressions following correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and Emervel Deep Lidocaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradermal injection | Experimental | Emervel Classic Lidocaine and/or Emervel Deep Lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emervel Classic Lidocaine | Device | Treatment of wrinkles and folds |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment impact on facial expressions | Perception of naturalness | 1 month after touch-up treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by assessment of local tolerability | 2 weeks after first treatment | |
| Safety by assessment of Adverse Events | 0-13 months | |
| Treating investigator satisfaction with treatment outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cologne | Germany | |||||
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| Emervel Deep Lidocaine |
| Device |
Treatment of wrinkles and folds |
|
Questionnaire |
| 1 month after touch-up |
| Subject satisfaction with treatment outcome | Questionnaires | 1 month after touch-up |
| Nasolabial fold severity | WSRS photo scale | Before treatment and 2 weeks after first treatment and 1 month after touch-up |
| Aesthetic improvement of lower face | GAIS | 1 month after touch-up |
| Darmstadt |
| Germany |
| Munich | Germany |