NL-OMON37130
Completed
Not Applicable
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) - VOLIFT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- gezichtveroudering
- Sponsor
- Allergan Pharmaceuticals Ireland
- Enrollment
- 23
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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