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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 7 years ago
What is this trial about?
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.
