Status:
COMPLETED
A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
Lead Sponsor:
Allergan
Conditions:
Infraorbital Hollowing
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief 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
- 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.
Exclusion
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2019
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT03418545
Start Date
January 26 2018
End Date
August 22 2019
Last Update
November 15 2021
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Christopher I. Zoumalan MD Inc.
Beverly Hills, California, United States, 90212
2
Steve Yoelin MD Medical Associate, Inc.
Newport Beach, California, United States, 92663
3
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
4
Facesplus, Inc.
San Diego, California, United States, 92121