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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05454033 | A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China With Fine Lines Around the Mouth | PHASE3 | COMPLETED | 198 | — | — | Sep 7, 2022 | Sep 3, 2024 | Dec 2, 2025 | 11 | China |
Responder status based on the Evaluating Investigator's (EI's) live assessment of perioral lines. The POLSS is a 4-point scale from 0 = None, 1 = Mild, 2 = Moderate, to 3 = Severe. An improvement of 1 or more points is an improvement in visibility of perioral lines.
| Arm | Type | Description |
|---|---|---|
| JUVÉDERM® VOLITE™ | EXPERIMENTAL | Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment. |
| Control - No Treatment | OTHER | Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment. |
| Name | Type | Description |
|---|---|---|
| JUVÉDERM® VOLITE™ | DEVICE | Injection, intradermal |
| Control | OTHER | No-treatment control |
Inclusion Criteria: * Has moderate or severe perioral lines (Perioral Lines at Rest Severity Scale \[POLSS\] Grades 2 or 3) as assessed by the Evaluating Investigator (EI). * Participants seeking improvement of lines, hydration, and skin smoothness in perioral area. * Is able to achieve a 1-point i...