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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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