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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05088980 | Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbital Hollowing in Chinese Adult Participants | PHASE3 | COMPLETED | 160 | — | — | Oct 19, 2021 | Nov 29, 2023 | Nov 25, 2024 | 7 | China |
A "responder" is a participant with at least 1- grade improvement on the Allergan Infraorbital Hollows Scale (AIHS) in both infraorbital areas. AIHS is a 5-point ordinal scale developed by Allergan to grade the severity of infraorbital hollowing (0 = None, 4 = Extreme).
| Arm | Type | Description |
|---|---|---|
| VOLBELLA with Lidocaine | EXPERIMENTAL | Participants will receive VOLBELLA with Lidocaine on Day 1 and followed for 12 months. |
| Control Group | PLACEBO_COMPARATOR | Participants will be followed for 3 months. Participants can opt to receive VOLBELLA with Lidocaine after 3 months and followed for 9 months. |
| Name | Type | Description |
|---|---|---|
| VOLBELLA with Lidocaine | DEVICE | Facial Injection |
Inclusion Criteria: * Participants seeking improvement of infraorbital hollowing. * Has Moderate or Severe infraorbital hollowing (grade 2 or 3 on the AIHS) for each eye as assessed by the evaluating investigator (i.e., both eyes must qualify but do not need to have the same score). * Treating Inve...