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JUVÉDERM VOLUX

Phase 3

Chin Retrusion | Unknown | Other |AbbVie Inc.|Last Updated: Aug 21, 2023

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 Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04559984JUVÉDERM VOLUX® for Chin Retrusion in ChinaPHASE3 COMPLETED 150Oct 15, 2020Aug 26, 2022Aug 21, 20237 China
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Study Endpoints
Primary Endpoints
Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
Change from Baseline to Week 24

The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion.

Secondary Endpoints
China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24
Week 24
Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
Week 24
Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24
Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JUVÉDERM VOLUX®EXPERIMENTALParticipants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator.
Control- No treatmentOTHERNo-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.
Interventions
NameTypeDescription
JUVÉDERM VOLUX®DEVICEJUVÉDERM VOLUX® injectable gel
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Participant must be at least 18 years of age at the time of signing the ICF * Male and female * Participants of Chinese descent * Participants seeking improvement of chin retrusion * Chin retrusion (G-Sn-Pog angle of \< 172.5°) based on calculations of facial angle derived fro...

Countries:China
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