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Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Juvederm Ultra Injectable Gel with Lidocaine |
|
| 2 | Active Comparator | Restylane Injectable Gel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine | Device | Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Pain Score | Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative Pain | A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niagara Falls | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20936295 | Background | Smith SR, Jones D, Thomas JA, Murphy DK, Beddingfield FC 3rd. Duration of wrinkle correction following repeat treatment with Juvederm hyaluronic acid fillers. Arch Dermatol Res. 2010 Dec;302(10):757-62. doi: 10.1007/s00403-010-1086-8. Epub 2010 Oct 9. |
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Enrollment:32 Study Start Date: November 2008 Study Completion Date: February 2009 Primary Completion Date: November 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Participants | Each participant received Juvederm on one side of the face and Restylane on the other side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | Each participant received Juvederm on one side of the face and Restylane on the other side. |
| 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, 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 | Procedural Pain Score | Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
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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 | Juvederm Ultra Injectable Gel With Lidocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site swelling | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven P. James, MD, VP, Global Medical Affairs | Allergan, Inc. | 714-246-4500 | james_steven@allergan.com |
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| A gel of hyaluronic acid (concentration of 20 mg/mL) | Device | Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL |
|
|
| 1 day |
| Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity | Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF | Day 0, Day 14 |
| Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity | Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF | Day 0, Day 14 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Comparative Pain | A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented. | Posted | Number | percent of participants | 1 day |
|
|
|
| Secondary | Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity | Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF | Posted | Mean | Standard Deviation | units on a scale | Day 0, Day 14 |
|
|
|
| Secondary | Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity | Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF | Posted | Mean | Standard Deviation | units on a scale | Day 0, Day 14 |
|
|
|
| 0 |
| 32 |
| 2 |
| 32 |
| EG001 | Restylane | 0 | 32 | 8 | 32 |
| Injection site pain | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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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 more than 60 days but 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 |
|---|
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| Juvederm with Lidocaine slightly more painful than |
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| Juvederm with Lidocaine more painful than Restylan |
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