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This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Silk with Lidocaine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Silk with Lidocaine | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, California | Beverly Hills | California | United States | |||
| United States, California |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Silk With Lidocaine | Restylane Silk with Lidocaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Silk With Lidocaine | Restylane Silk with Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine | Posted | Count of Participants | Participants | 12 weeks |
|
|
Adverse event data was collected from screening through 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restylane Silk With Lidocaine | Restylane Silk with Lidocaine | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US A&C Clinical Operations | Galderma R&D, LLC | 8179615111 | courtney.maguire@galderma.com |
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| San Diego |
| California |
| United States |
| United States, Florida | Miami | Florida | United States |
| United States, Georgia | Roswell | Georgia | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 60 |
| 0 |
| 60 |
| 11 |
| 60 |
| Pain | General disorders |
|
| Swelling | General disorders |
|
| Chapped Lips | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis Ulcerative | Gastrointestinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
Any and all data resulting from the Study will not be presented or published in any form or media by the PI without the prior written consent of the Sponsor.