A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation
Condition: Lip Augmentation
Intervention: Juvéderm® VOLIFT™ with Lidocaine
Intervention description: Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: All participants will sign an informed consent form, and begin at the Screening Visit. Filler treatment (Juvéderm® VOLIFT™ with Lidocaine) will be performed at (Initial Treatment visit) and data will be collected at this visit for all relevant parameters as per the Schedule of Study Procedures, Treatments and Assessments. Fourteen days after the initial treatment, participants will return to the clinic and the Investigator will assess whether a Touch-up treatment is to be performed at this visit. Follow up visits will occur at Day 30 and 3, 6, and 12 months after the last treatment.
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an open-label, multi-center, study where eligible participants will undergo treatment
      with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip augmentation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or older

          -  Signed the Institutional Independent Ethics Committee (IEC)-approved informed consent
             form prior to any study-related procedures being performed

          -  Accept the obligation not to receive any other facial procedures or treatments
             anywhere in the lower face (below the orbital rim), neck, and oral cavity at any time
             during the study that are not related to the study

          -  Women of childbearing potential must have a negative urine pregnancy test before each
             injectable treatment and practice a reliable method of contraception throughout the
             study

          -  Ability to follow study instructions and likely to complete all required visits and
             assessments, as assessed by the Investigator.

        Exclusion Criteria:

          -  Has lip tattoos, piercings, facial hair, or scars that would interfere with
             visualization of the lips and perioral area

          -  Has dentures or any device covering all or part of the upper palate, and/or severe
             malocclusion or dentofacial or maxillofacial deformities

          -  Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation)
             within 6 weeks before enrollment or is planning to undergo any of these procedures
             during the study

          -  Has ever undergone facial plastic surgery or received permanent facial implants (e.g.,
             polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or
             neck, or is planning to be implanted with any of these products during the study

          -  Has undergone semi-permanent dermal filler treatment (e.g., hyaluronic acid, calcium
             hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within
             24 months before enrollment or is planning to undergo such treatment during the study

          -  Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense
             pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or
             non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections
             in the lower face (below the orbital rim) within 6 months before enrollment or is
             planning to undergo any of these procedures during the study

          -  Has used any lip plumping products within 10 days before enrollment or is planning to
             use such products during the study (study treatment may be delayed as necessary to
             accommodate this 10-day washout period)

          -  Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle
             products for the lips or around the mouth within 90 days before enrollment or is
             planning to begin using such products during the study (participants who have been on
             a regimen of such products for at least 90 days are eligible for the study if they
             intend to continue their regimen throughout the study)

          -  Is on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or 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 gingko) within
             10 days of undergoing study device treatment (study treatment may be delayed as
             necessary to accommodate this 10-day washout period)

          -  Is on a concurrent regimen of lidocaine or structurally related local anesthetics
             (e.g., bupivacaine)

          -  Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA)
             products, or Streptococcal protein, or is planning to undergo desensitization therapy
             during the study

          -  Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed
             wound in the mouth area

          -  Has porphyria

          -  Has epilepsy

          -  Has impaired cardiac conduction, severely impaired hepatic function, or severe renal
             dysfunction

          -  Has any uncontrolled disease

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Current enrollment in an investigational drug or device study, participation in such a
             study within 6 weeks before enrollment, or be planning to participate in another
             investigation during the course of this study

          -  Is an employee (or immediate relative of an employee) of the Investigator, Allergan,
             or a representative of Allergan