Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VOLUX XC, No-treatment control · 1 trial · 1 indication
The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
| Arm | Type | Description |
|---|---|---|
| VOLUX XC | EXPERIMENTAL | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. |
| No-treatment control | EXPERIMENTAL | No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period. |
| Name | Type | Description |
|---|---|---|
| VOLUX XC | DEVICE | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. |
| No-treatment control | OTHER | No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period. |
Inclusion Criteria: * Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3 * Treating Investigator (TI) considers the subject's jaw amen...
VOLUX XC is an investigational injectable gel studied for restoring jawline definition. It was evaluated in a Phase 3 clinical trial in the United States for this aesthetic indication. The product is being developed by AbbVie Inc. (NYSE: ABBV) and is not yet approved for this use.
VOLUX XC is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie conducted a Phase 3 clinical trial to study the safety and effectiveness of VOLUX XC for restoring jawline definition.
VOLUX XC is in Phase 3 clinical development. A Phase 3 study, identified as NCT03712137, has been completed. This trial investigated the safety and effectiveness of VOLUX XC injectable gel for restoring jawline definition. The product remains investigational and has not been approved by regulatory authorities.
VOLUX XC has one completed Phase 3 clinical trial, registered as NCT03712137. This study, titled 'Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition,' enrolled 206 participants in the United States. The trial was controlled and randomized, though not double-blinded.
Yes, VOLUX XC is also known as JUVÉDERM VOLUX™ XC. The Phase 3 clinical trial for jawline definition used this full name. The product is an injectable gel developed by AbbVie Inc. and is being studied for restoring jawline definition.