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VOLBELLA with Lidocaine · 1 trial · 1 indication
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...
VOLBELLA with Lidocaine is an investigational injectable treatment being studied for correcting infraorbital hollowing, the sunken appearance under the eyes, in adult participants. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
VOLBELLA with Lidocaine is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the product's effectiveness and safety for treating infraorbital hollowing.
VOLBELLA with Lidocaine is in Phase 3 clinical development. It is an investigational product and has not yet received regulatory approval. A Phase 3 study has been completed to assess its use in correcting infraorbital hollowing.
VOLBELLA with Lidocaine has one completed Phase 3 trial, NCT05088980, which evaluated its effectiveness and adverse events in correcting infraorbital hollowing in Chinese adult participants. The study enrolled 160 participants and was placebo-controlled.
VOLBELLA with Lidocaine is part of the JUVEDERM VOLBELLA product family. The clinical trial NCT05088980 specifically studied JUVEDERM VOLBELLA with Lidocaine injection for correcting infraorbital hollowing in Chinese adults.