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The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.
This will be an open, multi-centre study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azzalure and Restylane | Other | All subjects will be injected with Azzalure and Restylane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A (Azzalure) | Drug | Powder for solution for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction for the Full Face | based on the subject's satisfaction questionnaire | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement From Baseline | The scale responses are: -1 indicating "worse", 0 indicating "no change", 1 indicating "improved", 2 indicating "much improved" and 3 indicating "very much improved". | Week 3 |
| Related Adverse Event |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma investigational site | Bordeaux | France | ||||
| Galderma investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azzalure and Restylane | All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azzalure and Restylane | All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh) |
| 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 | Subject Satisfaction for the Full Face | based on the subject's satisfaction questionnaire | only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis | Posted | Number | percentage of total subjects | Month 6 |
|
|
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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 | Azzalure and Restylane | All subjects will be injected with Azzalure and Restylane Botulinum Toxin Type A (Azzalure): Powder for solution for injection Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | administration site conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma | (33) 4 92 38 67 33 | may.ma@galderma.com |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Restylane ranges |
| Device |
Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh) |
|
Number of subjects reporting related adverse events
| Month 6 |
| Metz |
| France |
| Galderma investigational site | Madrid | Spain |
| Galderma investigational site | London | United Kingdom |
| Galderma investigational site | Street | United Kingdom |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Global Aesthetic Improvement From Baseline | The scale responses are: -1 indicating "worse", 0 indicating "no change", 1 indicating "improved", 2 indicating "much improved" and 3 indicating "very much improved". | Posted | Number | percentage of total subjects | Week 3 |
|
|
|
| Secondary | Related Adverse Event | Number of subjects reporting related adverse events | Posted | Number | participants | Month 6 |
|
|
|
| 2 |
| 60 |
| 18 |
| 60 |
| Cerebral infarction | Nervous system disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| contusion | Injury, poisoning and procedural complications |
|
| headache | Nervous system disorders |
|
| Skin swelling | Skin and subcutaneous tissue disorders |
|
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |