Clinical trial NCT03418545: A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
Official title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Correction of Infraorbital Hollowing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infraorbital Hollowing
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-01
Enrollment: 163
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Percentage of Participants With at Least a 1-point Improvement Change From Baseline on the Allergan Infraorbital Hollows Scale (AIHS) Based on Evaluating Investigator's (EI) Assessment
timeFrame: Baseline (Screening) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC arm) or Month 3 post randomization (No-treatment Control arm)
Secondary outcomes:
measure: Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on EI's Assessment of the Global Aesthetic Improvement Scale (GAIS) at Month 3 After the Last Treatment
timeFrame: Baseline (Randomization) to Month 3 post last treatment (JUVÉDERM® VOLBELLA™ XC) or Month 3 post randomization (No-treatment Control arm)
measure: Percentage of Participants Improved or Much Improved in the Overall Aesthetic Assessment Based on Participant's Assessment of the GAIS at Month 3 After the Last Treatment
timeFrame: Baseline (Randomization) to Month 3 post last treatment
measure: Mean Change From Baseline in Rasch-Transformed Score Based on Participant Responses on the FACE-Q™ Appraisal of Lower Eyelids Questionnaire to Month 3 After the Last Treatment
timeFrame: Baseline (Randomization) to Month 3 post last treatment
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Christopher I. Zoumalan MD Inc.
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Associate, Inc.
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
city: San Diego
country: United States
facility: Facesplus, Inc.
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Boca Raton
country: United States
facility: Steven Fagien M.D.F.A.C.S.
state: Florida
city: Sarasota
country: United States
facility: Center For Sight
state: Florida
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic and General Dermatology
state: Louisiana
city: Montclair
country: United States
facility: Image Dermatology, P.C.
state: New Jersey
city: Latham
country: United States
facility: Williams Plastic Surgery Specialists
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions, PA.
state: North Carolina
city: Durham
country: United States
facility: Duke Aesthetic Center
state: North Carolina
city: Nashville
country: United States
facility: Brian Biesman, MD
state: Tennessee
city: Bellaire
country: United States
facility: Precision Dermatology
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
Study officials:
affiliation: Allergan
name: Steve Abrams
role: STUDY_DIRECTOR
References: