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A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM VOLIFT™ | Experimental | All subjects receiving treatment with JUVÉDERM VOLIFT™. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crosslinked hyaluronic acid dermal filler | Device | All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) | Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). | Day 0, Day 14, Month 1, Month 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Allergan Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cologne | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28165349 | Background | Sattler G, Philipp-Dormston WG, Van Den Elzen H, Van Der Walt C, Nathan M, Kolodziejczyk J, Kerson G, Dhillon B. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017 Feb;43(2):238-245. doi: 10.1097/DSS.0000000000000939. |
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| ID | Title | Description |
|---|---|---|
| FG000 | JUVÉDERM VOLIFT™ | All subjects receiving treatment with JUVÉDERM VOLIFT™. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | JUVÉDERM VOLIFT™ | All subjects receiving treatment with JUVÉDERM VOLIFT™. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) | Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Month 12 |
|
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The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all treated subjects.
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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 | JUVÉDERM VOLIFT™ | All subjects receiving treatment with JUVÉDERM VOLIFT™. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale |
Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied). |
| Day 14, Month 1, Month 9, Month 12 |
| Investigator Assessment of Ease of Injection Use on a 10-Point Scale | Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard). | Day 0, Day 14 |
| Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). | Day 0, Day 14, Month 1, Month 9, Month 12 |
| Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied). | Day 14, Month 1, Month 9, Month 12 |
| Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable). | Day 0, Day 14, Month 12, Month 12.5 |
| Darmstadt |
| Germany |
| Naarden | Netherlands |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0, Day 14, Month 1, Month 9 |
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| Secondary | Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale | Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14, Month 1, Month 9, Month 12 |
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| Secondary | Investigator Assessment of Ease of Injection Use on a 10-Point Scale | Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0, Day 14 |
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| Secondary | Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS | Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0, Day 14, Month 1, Month 9, Month 12 |
|
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| Secondary | Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale | Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Day 14, Month 1, Month 9, Month 12 |
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| Secondary | Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale | Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable). | Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point | Posted | Mean | Standard Deviation | Scores on a Scale | Day 0, Day 14, Month 12, Month 12.5 |
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|
| 0 |
| 70 |
| 0 |
| 70 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
|
| Day 14 - Left |
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| Month 1 - Right (N=66) |
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| Month 1 - Left (N=66 |
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| Month 9 - Right (N=66) |
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| Month 9 - Left (N=66) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=65) |
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| Title | Measurements |
|---|---|
|
| Day 14 - Left |
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| Month 1 - Right (N=66) |
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| Month 1 - Left (N=65) |
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| Month 9 - Right (N=66) |
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| Month 9 - Left (N=66) |
|
| Month 12 - Right (N=54) |
|
| Month 12 - Left (N=54) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=54) |
|
| Title | Measurements |
|---|---|
|
| Pain Intensity Day 14 - Left (N=66) |
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| Pain Intensity Month 12 - Right (N=51) |
|
| Pain Intensity Month 12 - Left (N=51) |
|
| Pain Intensity Month 12.5 - Right (N=12) |
|
| Pain Intensity Month 12.5 - Left (N=12) |
|
| Swelling Intensity Day 0 - Right |
|
| Swelling Intensity Day 0 - Left |
|
| Swelling Intensity Day 14 - Right (N=66) |
|
| Swelling Intensity Day 14 - Left (N=66) |
|
| Swelling Intensity Month 12 - Right (N=51) |
|
| Swelling Intensity Month 12 - Left (N=51) |
|
| Swelling Intensity Month 12.5 - Right (N=12) |
|
| Swelling Intensity Month 12.5 - Left (N=12) |
|
| Bruising Intensity Day 0 - Right |
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| Bruising Intensity Day 0 - Left |
|
| Bruising Intensity Day 14 - Right (N=66) |
|
| Bruising Intensity Day 14 - Left (N=66) |
|
| Bruising Intensity Month 12 - Right (N=51) |
|
| Bruising Intensity Month 12 - Left (N=51) |
|
| Bruising Intensity Month 12.5 - Right (N=12) |
|
| Bruising Intensity Month 12.5 - Left (N=12) |
|