A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
Condition: Infraorbital Hollowing
Intervention: JUVÉDERM VOLBELLA® XC injectable gel
Intervention description: JUVÉDERM® VOLBELLA™ XC dermal filler injected into the infraorbital and adjacent area.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM®
      VOLBELLA™ XC in adult participants seeking correction of hollowing of the tear troughs.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Age 22 or over and in good general health

          -  Has "Moderate" or "Severe" infraorbital hollowing (grade 2 or 3 on the Allergan
             Infraorbital Hollows Scale (AIHS)) for each eye as assessed by the Evaluating
             Investigator (i.e., both eyes must qualify but do not need to have the same score)

          -  Is able to complete effectiveness self-assessments without the use of glasses (contact
             lens use is acceptable if they will be used for all subject self-assessments)

          -  Ability to follow study instructions and likely to complete all required visits

          -  Written informed consent has been obtained

        EXCLUSION CRITERIA:

          -  Has hyperpigmentation in the infraorbital area (does not include dark circles under
             the eyes not due to hyperpigmentation)

          -  Has ever 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 ever undergone fat injections above the subnasale or is planning to undergo this
             procedure during the study

          -  Has tattoos, piercings, facial hair (i.e., beard, mustache), or scars that would
             interfere with visual assessment of the infraorbital hollows

          -  Has undergone volume augmentation with semipermanent dermal fillers (e.g., calcium
             hydroxyapatite, poly-L-lactic acid) or temporary dermal fillers in the malar area,
             temples, or around the eyes within 12 months before enrollment or is planning to
             undergo such treatment during the study

          -  Has begun using any new over-the-counter or prescription oral or topical, anti-wrinkle
             products within 30 days before enrollment or is planning to begin using such products
             during the study. Subjects who have been on a regimen of such products for at least 30
             days are eligible for the study if they intend to continue their regimen throughout
             the study)

          -  Has active or recurrent inflammation or infection in either eye

          -  Has active autoimmune disease

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Is an employee (or a relative of an employee) of the treating investigator (TI),
             evaluating investigator (EI), or Allergan, or a representative of Allergan

          -  Has a condition or is in a situation which in the TI's opinion may put the subject at
             significant risk, may confound the study results, or may interfere significantly with
             the participant's participation in the study.