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This is a prospective, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age group A | Subjects 30 to 40 years old |
| |
| Age group B | Subjects 40 to 50 years old |
| |
| Age group C | Subjects over 50 years old |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) | Device | All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Experience Measured by Patient Satisfaction Questionnaire | Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Normal, healthy subjects desiring aesthetic improvement
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Allergan Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24689357 | Result | Philipp-Dormston WG, Eccleston D, De Boulle K, Hilton S, van den Elzen H, Nathan M. A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvederm(R) VOLUMA(R) with Lidocaine in mid-face area. J Cosmet Laser Ther. 2014 Aug;16(4):171-9. doi: 10.3109/14764172.2014.910079. Epub 2014 May 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Age Group A | Subjects 30 to 40 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| FG001 | Age Group B | Subjects 40 to 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| FG002 | Age Group C | Subjects over 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Age Group A | Subjects 30 to 40 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| BG001 | Age Group B |
| 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 | Subject Experience Measured by Patient Satisfaction Questionnaire | Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy | Mean | Standard Deviation | Units on a scale | 3 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 | Age Group A | Subjects 30 to 40 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site hematoma | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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|
| Cologne |
| North Rhine-Westphalia |
| Germany |
| Naarden | Netherlands |
| Mere Green | United Kingdom |
Subjects 40 to 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| BG002 | Age Group C | Subjects over 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Age Group C | Subjects over 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. |
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Age Group B | Subjects 40 to 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. | 0 | 39 | 1 | 39 |
| EG002 | Age Group C | Subjects over 50 years old Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. | 0 | 57 | 2 | 57 |
| Injection site edema | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Injection site pain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
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| Pain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Swelling | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
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