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JUVÉDERM VOLUMA XC, No-treatment control · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| No Treatment then JUVÉDERM® VOLUMA® XC | OTHER | Participants 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® XC | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| JUVÉDERM® VOLUMA® XC | DEVICE | JUVÉDERM® VOLUMA® XC injectable gel |
| No-treatment control | OTHER | Participants received no treatment for 3 months during the Control Period. |
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...
JUVÉDERM VOLUMA XC is an injectable gel being studied for the correction of temple hollowing in adults aged 22 years and older. It is currently in Phase 3 clinical development and is considered investigational for this use.
JUVÉDERM VOLUMA XC is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
JUVÉDERM VOLUMA XC is in Phase 3 clinical development for the correction of temple hollowing. It is an investigational product and has not been approved for this indication.
JUVÉDERM VOLUMA XC has one completed Phase 3 clinical trial, identified as NCT04414397. This study evaluated the injectable gel for correction of temple hollowing in 205 adult participants aged 22 years and older in the United States and Puerto Rico.
JUVÉDERM VOLUMA XC is not FDA approved for the correction of temple hollowing. It is an investigational product currently in Phase 3 clinical development, and its safety and efficacy for this use have not been fully established.