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Hyaluronic Acid Injectable Gel
JUVÉDERM VOLBELLA® XC for Infraorbital Hollowing
Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (screening) to month 3 post last treatment (juvéderm® volbella™ xc arm) or month 3 post randomization (no-treatment control arm)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (randomization) to month 3 post last treatment (juvéderm® volbella™ xc) or month 3 post randomization (no-treatment control arm)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (randomization) to month 3 post last treatment (juvéderm® volbella™ xc) or month 3 post randomization (no-treatment control arm)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
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
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
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
Side effects data
From 2019 Phase 3 trial • 163 Patients • NCT034185457%
Injection site bruising
7%
Injection site swelling
100%
80%
60%
40%
20%
0%
Study treatment Arm
JUVÉDERM® VOLBELLA™ Optional Treatment
JUVÉDERM® VOLBELLA™ Repeat Treatment
No-treatment Control
JUVÉDERM® VOLBELLA™ Initial Treatment
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: JUVÉDERM VOLBELLA® XCExperimental Treatment1 Intervention
JUVÉDERM® VOLBELLA™ XC injectable gel was injected into the infraorbital and adjacent area at Randomization as determined by the investigator. Participants were eligible to receive an optional touch-up treatment 1 month later and an optional repeat treatment 12 months after last treatment, if applicable. A maximum of 2.2 milliliter (mL) per side was injected for initial and touch-up treatments combined.
Group II: No-treatment ControlActive Control1 Intervention
Participants randomized to the No-treatment Control group completed a 3-month No-treatment Period. Participants were then eligible to receive optional treatment with JUVÉDERM® VOLBELLA™ XC injectable gel injected into the infraorbital and adjacent area followed by an optional touch-up treatment 1 month later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JUVÉDERM VOLBELLA® XC injectable gel
2018
Completed Phase 3
~170
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Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,491 Total Patients Enrolled
1 Trials studying Infraorbital Hollowing
160 Patients Enrolled for Infraorbital Hollowing
Steve AbramsStudy DirectorAllergan
1 Previous Clinical Trials
66 Total Patients Enrolled
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