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A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing

Sponsored by Allergan

About this trial

Last updated 5 years ago

Study ID

1932-701-008

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

22+ Years
All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

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.