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Dermal Filler

No Treatment then 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
Awards & highlights

Summary

This trial is testing a cosmetic filler called Juvederm® Voluma® XC on adults who want to fill in hollow areas in their temples. The filler works by adding volume and smoothness to the skin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment for reporting.

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
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
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 With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: No Treatment then JUVÉDERM® VOLUMA® XCExperimental Treatment2 Interventions
Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.
Group II: JUVÉDERM® VOLUMA® XCExperimental Treatment1 Intervention
Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JUVÉDERM® VOLUMA® XC
2014
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,626 Total Patients Enrolled
ALLERGAN, INC.Study DirectorAllergan
1 Previous Clinical Trials
209 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,316 Total Patients Enrolled
~39 spots leftby Sep 2025
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