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JUVÉDERM VOLUX

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

JUVÉDERM VOLUX · 1 trial · 1 indication

Phase 3 1
NCT04559984JUVÉDERM VOLUX® for Chin Retrusion in ChinaChin Retrusion
COMPLETED150 Analytics
PHASE3COMPLETED
JUVÉDERM VOLUX® for Chin Retrusion in China
Chin RetrusionUnlock trial analytics

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 to 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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Frequently asked questions about JUVÉDERM VOLUX

What is JUVÉDERM VOLUX used for?

JUVÉDERM VOLUX is an investigational product being studied for the treatment of chin retrusion, a condition where the chin is set back relative to the rest of the face. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes JUVÉDERM VOLUX?

JUVÉDERM VOLUX is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The product is part of the JUVÉDERM family of dermal fillers, though it is specifically being studied for chin augmentation.

What phase is JUVÉDERM VOLUX in?

JUVÉDERM VOLUX is in Phase 3 clinical development for chin retrusion. It is an investigational product, meaning it has not yet received regulatory approval and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is JUVÉDERM VOLUX in?

JUVÉDERM VOLUX has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT04559984. This trial, titled 'JUVÉDERM VOLUX® for Chin Retrusion in China,' enrolled 150 participants aged 18 years and older in China. The study was controlled but not double-blinded.

Is JUVÉDERM VOLUX FDA approved?

JUVÉDERM VOLUX is not FDA approved. It is an investigational product currently in Phase 3 clinical development for chin retrusion. Regulatory approval has not been granted, and the product remains under study to determine its safety and effectiveness.