A prospective, open label, multi-centre, observational, post-market study evaluating Juvéderm® Volift with Lidocaine for the correction of moderate to severe nasolabial folds (NLF)
- Conditions
- gezichtverouderingdermal fillersfacial aging
- Registration Number
- NL-OMON37130
- Lead Sponsor
- Allergan Pharmaceuticals Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
•Male or Female 18 years of age or older
•Has 2 fully visible, approximately symmetrical NLFs, and has a severity scores of 2 or 3 on the 5-point photographic NLFSS (range 0-4) for both NLFs, as judged by the Investigator
•Have a reasonable expectation for their correction by injection via deep dermis, as described in this 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
•Being in good health as in the opinion of the Investigator
•Has undergone cosmetic facial procedures [e.g., face-lift, or other surgeries] which may alter the appearance of the NLF 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 (or any amide-based anaesthetics), 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 enrolment 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, etc.)
•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 washout 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 anaesthetics structurally related to amide-type local anaesthetics
•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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this clinical investigation is to evaluate the impact<br /><br>of Juvéderm® Volift with Lidocaine treatment on the nasolabial fold severity as<br /><br>assessed by the Investigator using a NLF severity scale (NLFSS) at 12 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints of this clinical investigation are:<br /><br><br /><br>• Investigator assessment of NLF severity at 1 and 9 months after treatment<br /><br>using NLFSS<br /><br>• Subject assessment of NLF severity at 1, 9 and 12 months after treatment<br /><br>using NLFSS<br /><br>• Subject satisfaction with aesthetic outcome<br /><br>• Subject pain/swelling/bruising measurements<br /><br>• Investigator satisfaction with aesthetic outcome<br /><br>• Investigator ease of use (injection) measurements<br /><br>• Reported Adverse Events and Serious Adverse Events (AEs/SAEs) and incidents</p><br>