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Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Volyme | Experimental | Hyaluronic Acid |
|
| Restylane Lyft Lidocaine | Experimental | Hyaluronic Acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Volyme | Device | Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 4 weeks after last treatment, up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Female adult subject.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Vancouver | British Columbia | Canada | |||
| Galderma Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Volyme | Hyaluronic Acid Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization). |
| FG001 | Restylane Lyft Lidocaine | Hyaluronic Acid Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Volyme | Hyaluronic Acid Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization). |
| BG001 | Restylane Lyft Lidocaine | Hyaluronic Acid Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation). |
| 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 | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 4 weeks after last treatment, up to 6 weeks |
|
4 months
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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 Volyme | Hyaluronic Acid Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | (817) 961-500 | aestheticclinicaltrials@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2020 | May 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2021 | May 10, 2022 | SAP_001.pdf |
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| Restylane Lyft Lidocaine | Device | Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation). |
|
| Woodbridge |
| Ontario |
| Canada |
| Galderma Study Site | Montreal | Quebec | Canada |
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
|
| Fitzpatrick Skin Type (FST) | I (white, very fair, red or blond hair, blue eyes, freckles), II (white, fair, red or blond hair; blue, hazel or green eyes), III (cream white, fair with any eye or hair color, very common), IV (brown, typical Mediterranean Caucasian skin), V (dark brown, Middle Eastern skin type), VI (black) | Count of Participants | Participants |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Restylane Lyft Lidocaine | Hyaluronic Acid Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation). | 0 | 30 | 0 | 30 | 1 | 30 |
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