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

Allergan

Status

Completed

Conditions

Moderate to Severe Nasolabial Folds

Treatments

Device: Crosslinked hyaluronic acid dermal filler

Study type

Interventional

Funder types

Industry

Identifiers

NCT01680497

MAF/AGN/MED/FIL/018

Details and patient eligibility

About

A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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