Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05316233 | A Study to Assess Adverse Events and Change in Disease Activity of JUVÉDERM® VOLITE™ XC Injectable Gel for Change in Neck Appearance in Adult Participants | PHASE3 | COMPLETED | 159 | — | — | May 2, 2022 | Sep 12, 2024 | Apr 29, 2025 | 15 | United States |
A "responder" is a participant with at least 1-grade improvement on the ATNLS. ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
| Arm | Type | Description |
|---|---|---|
| VOLITE XC | EXPERIMENTAL | Participants will receive VOLITE XC for initial treatment and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. |
| Control Group | OTHER | The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 Months. |
| Name | Type | Description |
|---|---|---|
| VOLITE XC | DEVICE | Intradermal Injection |
Inclusion Criteria: * Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection. * Participants seeking improvement of transverse neck lines. * Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live asse...