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The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermal Filler for Indication: Restylane Lyft with Lidocaine | Experimental | Participants will receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline with an optional touch-up treatment at 1 month after initial treatment and an optional retreatment 12 months after the last treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lyft with Lidocaine | Device | Sterile gel of hyaluronic acid. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment | An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational product (IP). TEAEs that are related to the device and/or injection procedure after the Month 12 optional retreatment will be reported. | From Month 12 up to 3 months after optional retreatment (i.e. Month 15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Contact | 817-961-5000 | +1 | clinical.studies@galderma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site # 8680 | Westport | Connecticut | 06880 | United States |
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| Galderma Investigational Site # 8774 | Boynton Beach | Florida | 33437 | United States |
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| Galderma Investigational Site # 7030 | Coral Gables | Florida | 33134 | United States |
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| Galderma Investigational Site # 8682 | Coral Gables | Florida | 33134 | United States |
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| Galderma Investigational Site # 7042 | Atlanta | Georgia | 30331 | United States |
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| Galderma Investigational Site # 7043 | Bethesda | Maryland | 20852 | United States |
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| Galderma Investigational Site # 7118 | Nashville | Tennessee | 37203 | United States |
| Galderma Investigational Site # 8662 | Spring | Texas | 77388 | United States |
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