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Dermal Filler
JUVÉDERM VOLUMA® XC for Temporal 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
Participants in general good health
Participants seeking improvement of temple hollowing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of Juvederm Voluma XC, an injectable gel, for correcting temple hollowing in adults.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are in overall good health.
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Participants who wish to reduce temple hollowing.
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You are in general good physical and mental condition.
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Participants wanting to reduce temple hollowing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events
Participants with at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) using the Allergan Temple Hollowing Scale (ATHS)
Secondary outcome measures
Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 3
Change from baseline to Month 3 on participants responses on FACE-Q Satisfaction with Temples questionnaire
Percentage of Participants "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the Evaluating Investigator
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: No-treatment controlExperimental Treatment1 Intervention
Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later.
Group II: JUVÉDERM VOLUMA® XC TreatmentExperimental Treatment1 Intervention
Participants received JUVÉDERM VOLUMA® XC injectable gel treatment in both temples followed by an optional touch-up treatment 30 days later.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JUVÉDERM VOLUMA® XC
2020
Completed Phase 3
~430
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Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
275,588 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,278 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Skin Care and Laser Physicians of Beverly Hills /ID# 232967
What portion of applicants met pre-screening criteria?
Met criteria
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