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JUVÉDERM VOLUMA XC, No-treatment control

Phase 3

Temple Hollowing | Unknown | Other |AbbVie Inc.|Last Updated: Apr 25, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment205
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04414397A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years OldPHASE3 COMPLETED 205May 28, 2020Oct 17, 2022Apr 25, 202415 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
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
Baseline, Month 3 (Control Period)

The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.

Number of Participants With Adverse Events
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

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.

Secondary Endpoints
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
Month 3 (Control Period)
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 Participants at Month 3
Month 3 (Control Period)
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3
Baseline, Month 3 (Control Period)
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
No Treatment then JUVÉDERM® VOLUMA® XCOTHERParticipants 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.
JUVÉDERM® VOLUMA® XCEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
JUVÉDERM® VOLUMA® XCDEVICEJUVÉDERM® VOLUMA® XC injectable gel
No-treatment controlOTHERParticipants received no treatment for 3 months during the Control Period.
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Eligibility Criteria
Age Range22 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Participants in general good health * Participants seeking improvement of temple hollowing Exclusion Criteria: * Temple hollowing due to trauma, congenital malformations, or lipodystrophy * Temporomandibular joint dysfunction or any other jaw issues * Recurrent temporal head...

Countries:United StatesPuerto Rico
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