Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds

Study Overview
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Brief Summary
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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

Conditions
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Moderate to Severe Nasolabial Folds

Intervention / Treatment
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* Device: Crosslinked hyaluronic acid dermal filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older Have 2 fully visible, approximately symmetrical nasolabial folds and has severity scores of 2 or 3 on the 5-point photographic nasolabial fold severity scale (range 0-4) for both nasolabial folds, as judged by the Investigator Have a reasonable expectation for correction by injection via deep dermis, as described in the protocol Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face (below the orbital rim) for the duration of the study Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent prior to any study-related procedures being performed Be in good health as in the opinion of the Investigator Exclusion Criteria: Has undergone cosmetic facial procedures (e.g., face lift or other surgeries) which may alter the appearance of the nasolabial fold area Cosmetic injections in the lower two-thirds of the face (below the orbital rim), within 6 months prior to entry in the study, or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry Has undergone volumizing of the mid/lower face within 9 months prior to study entry Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded poly-tetrafluoroethylene) anywhere in the lower face (below the orbital rim), or be planning to be implanted with any of these products at any time during the study Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (an any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study Be a pregnant female, lactating, or planning to become pregnant at any time during the study Be a female of childbearing potential not using a reliable means of contraception Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression) Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease) Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications) Have a history of skin cancer Suffer from porphyria Have epilepsy, which is not controlled by anti-epilepsy therapy Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes) Have a history of treatment with interferon Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day period Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics Have impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JUVÉDERM VOLIFT™<br>All subjects receiving treatment with JUVÉDERM VOLIFT™. | Device: Crosslinked hyaluronic acid dermal filler<br>* 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.<br>* Other names: JUVÉDERM VOLIFT™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |