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JUVÉDERM VOLUMA with Lidocaine · 1 trial · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | EXPERIMENTAL | Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment |
| Control- No treatment | NO_INTERVENTION | No treatment is administered. Optional treatment at month 6. |
| Name | Type | Description |
|---|---|---|
| JUVÉDERM® VOLUMA® with Lidocaine | DEVICE | JUVÉDERM® VOLUMA® with Lidocaine injectable gel |
Inclusion Criteria: * Participant must be 18 or over, at the time of signing the ICF * Participants seeking improvement of temple hollowing * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol * Written in...
JUVÉDERM VOLUMA with Lidocaine is used for the correction of temple hollowing. It is an investigational product being studied in a Phase 3 clinical trial in a Chinese population. The product is developed by AbbVie Inc., which trades under the ticker ABBV.
JUVÉDERM VOLUMA with Lidocaine is developed by AbbVie Inc., a biopharmaceutical company traded on the stock exchange under the ticker ABBV. The product is being investigated for the correction of temple hollowing.
JUVÉDERM VOLUMA with Lidocaine is in Phase 3 clinical development. It is being studied for the correction of temple hollowing. The product is investigational and has not been approved for this use.
JUVÉDERM VOLUMA with Lidocaine is associated with one completed Phase 3 clinical trial, identified as NCT04891419. This trial evaluated the product for the correction of temple hollowing in a Chinese population, enrolling 168 participants.
JUVÉDERM VOLUMA with Lidocaine is not FDA approved for the correction of temple hollowing. It is an investigational product currently in Phase 3 clinical development. The product is being studied for this indication but has not received regulatory approval.