A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Moderate to Severe Nasolabial Folds

Intervention / Treatment
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* Device: JUVEDERM VOLIFT® XC
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 visible moderate to severe nasolabial folds Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study Exclusion Criteria: Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months Received semi-permanent fillers or permanent facial implants anywhere in the lower face

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOLIFT® XC NLFs<br>Nasolabial folds treated with JUVEDERM VOLIFT® XC. | Device: JUVEDERM VOLIFT® XC<br>* 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.<br>|
| Active Comparator: Control NLFs<br>Nasolabial folds treated with Control. | Device: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |