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The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emervel Lips | Experimental | Emervel Lips |
|
| Juvederm Ultra Smile | Experimental | Juvederm Ultra Smile |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emervel Lips | Device | Lip treatment of both upper and lower lip |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability | To assess local tolerability after treatment including erythema, bruising, itching, swelling, pain/ tenderness at 14 days. Number of subjects reporting the events will be analysed. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| AE reporting | To evaluate long-term safety throughout the study period | 24 weeks |
| Global Aesthetic Improvement Scale (GAIS) | To evaluate esthetic change of lips from baseline using GEIS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Said Hilton, MD | Medical Skin Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Skin center | Düsseldorf | Germany |
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| ID | Term |
|---|---|
| C562489 | Lymphoid Interstitial Pneumonia |
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| Juvederm Ultra Smile |
| Device |
Lip treatment of both upper and lower lip |
|
| Week 2 to week 24 |
| Lip Fullness Grading Scale (LFGS) | To evaluate esthetic change of lips from baseline using LFGS | 0-24 weeks |
| Subject's satisfaction | To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire | 0-24 weeks |