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A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLIFT® XC NLFs | Experimental | Nasolabial folds treated with JUVEDERM VOLIFT® XC. |
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| Control NLFs | Active Comparator | Nasolabial folds treated with Control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVEDERM VOLIFT® XC | Device | Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) | Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening. | Baseline, Month 6 |
| Percentage of Nasolabial Folds With ≥1-Point Improvement | Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Nasolabial Folds With ≥1-Point Improvement | Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported. | Baseline, Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center P.C. | Birmingham | Alabama | 35205 | United States | ||
| Vitiligo and Pigmentation Institute of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29701621 | Background | Monheit G, Beer K, Hardas B, Grimes PE, Weichman BM, Lin V, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. Dermatol Surg. 2018 May;44(5):670-678. doi: 10.1097/DSS.0000000000001529. |
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126 subjects were enrolled (Enrolled Population); 123 subjects were randomized and treated (Modified Intent-to-Treat). Each subject had one nasolabial fold treated with JUVEDERM VOLIFT® XC and one treated with control. After initial treatment, subjects were eligible for touch-up, asymmetry correction, and repeat treatment per protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | JUVEDERM VOLIFT® XC | Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Control | Device | Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction. |
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| Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score | Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | Baseline, Month 12 |
| Los Angeles |
| California |
| 90036 |
| United States |
| San Francisco | California | 94115 | United States |
| Dermatology Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
| Skin Research Institute | Coral Gables | Florida | 33146 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Chicago | Illinois | 60611 | United States |
| Received Touch-up Treatment |
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| Received Asymmetry Correction |
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| Received Repeat Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-Treat (mITT): all randomized and treated subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | JUVEDERM VOLIFT® XC | Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control 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 | ||||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) | Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening. | modified intent-to-treat (mITT): all randomized and treated subjects | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
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| Primary | Percentage of Nasolabial Folds With ≥1-Point Improvement | Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported. | modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure | Posted | Number | 95% Confidence Interval | Percentage of Nasolabial Folds | Baseline, Month 6 |
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| Secondary | Percentage of Nasolabial Folds With ≥1-Point Improvement | Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported. | modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure | Posted | Number | 95% Confidence Interval | Percentage of Nasolabial Folds | Baseline, Month 12 |
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| Secondary | Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score | Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | modified intent-to-treat (mITT): all randomized and treated subjects with data at this time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 12 |
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The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
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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 VOLIFT® XC During Initial/Touch Up | Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period. | 0 | 123 | 29 | 123 | ||
| EG001 | Control During Initial/Touch Up Treatment Period | Nasolabial folds treated with Control during the Initial/Touch Up period. | 0 | 123 | 27 | 123 | ||
| EG002 | Not at NLF During Initial/Touch Up Treatment Period | Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side. | 5 | 123 | 0 | 123 | ||
| EG003 | JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment | Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period. | 0 | 93 | 19 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment | Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment |
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| Diverticulitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment | Assessed as unrelated to treatment |
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| Pneumonia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment | Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment | Assessed as unrelated to treatment |
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| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment | Assessed as unrelated to treatment |
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| Brain Hypoxia | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment | Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment | Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment |
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| Seizure | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment | Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment | Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment |
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| Ovarian Cyst | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment | Assessed as unrelated to treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Induration | General disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Injection Site Mass | General disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Injection Site Bruising | General disorders | MedDRA version 18.1 | Non-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 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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allergan Inc., | Allergan, Inc | clinicaltrials@allergan.com |
| Month 6 (N=117, 117) |
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