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Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Kysse | Other | Hyaluronic acid |
|
| Restylane Kysse with other HA | Other | Hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Device | Injectable gel for lip augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Treatment With Restylane Kysse Using GAIS | The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved. | 8 weeks after last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study Site | Montreal | Canada | ||||
| Galderma Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Kysse | Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation |
| FG001 | Restylane Kysse With Other HA | Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Kysse | Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation |
| BG001 | Restylane Kysse With Other HA | Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Kysse Using GAIS | The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved. | Posted | Count of Participants | Participants | 8 weeks after last treatment |
|
8 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 Kysse | Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Bruising | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Galderma Research & Development, Aesthetics | 817-961-5655 | 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 | Mar 25, 2019 | Feb 9, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2018 | Apr 17, 2020 | SAP_000.pdf |
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| Hyaluronic acid | Device | Injectable gel. Lip Augmentation and other wrinkles/folds |
|
|
| Toronto |
| Canada |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 10 |
| 19 |
| EG001 | Restylane Kysse With Other HA | Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds | 0 | 40 | 0 | 40 | 25 | 40 |
| Implant Site Pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Implant Site Oedema | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Impalnt site erythema | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Implant Site Swelling | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Implant Site Reaction | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Implant Site Dysaesthesia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Varicella zoster virus infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Animal Scratch | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
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