Clinical trial NCT01680497: Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate to Severe Nasolabial Folds
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
timeFrame: Month 12
Secondary outcomes:
measure: Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
timeFrame: Day 0, Day 14, Month 1, Month 9
measure: Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
timeFrame: Day 14, Month 1, Month 9, Month 12
measure: Investigator Assessment of Ease of Injection Use on a 10-Point Scale
timeFrame: Day 0, Day 14
measure: Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
timeFrame: Day 0, Day 14, Month 1, Month 9, Month 12
measure: Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
timeFrame: Day 14, Month 1, Month 9, Month 12
measure: Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
timeFrame: Day 0, Day 14, Month 12, Month 12.5
Other outcomes:
Locations:
city: Darmstadt
country: Germany
city: Koln
country: Germany
city: Naarden
country: Netherlands
Study officials:
affiliation: Allergan Medical
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sattler G, Philipp-Dormston WG, Van Den Elzen H, Van Der Walt C, Nathan M, Kolodziejczyk J, Kerson G, Dhillon B. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017 Feb;43(2):238-245. doi: 10.1097/DSS.0000000000000939.