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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT01680497
First received: September 4, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Moderate to Severe Nasolabial Folds
Device: Crosslinked hyaluronic acid dermal filler

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Investigator assessment of nasolabial fold severity using the 5-point NLFSS (nasolabial fold severity scale) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JUVÉDERM VOLIFT™
All subjects receiving treatment with JUVÉDERM VOLIFT™
Device: Crosslinked hyaluronic acid dermal filler
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.
Other Name: JUVÉDERM VOLIFT™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680497

Locations
Germany
Darmstadt, Germany
Koln, Germany
Netherlands
Naarden, Netherlands
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Medical Monitor Allergan Medical
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01680497     History of Changes
Other Study ID Numbers: MAF/AGN/MED/FIL/018
Study First Received: September 4, 2012
Last Updated: June 17, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014