NCT05088980

Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbital Hollowing in Chinese Adult Participants

A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLBELLA With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aged appearance is often caused by an infraorbital hollowing, which is characterized as a sunken appearance of the eye that results in the casting of a dark shadow over the nasal lower eyelid, giving a fatigued appearance. This study will assess how safe and effective JUVEDERM VOLBELLA with Lidocaine is in correcting infraorbital hollowing in adult participants in China. VOLBELLA with Lidocaine is an investigational product being developed for the correction of infraorbital hollowing. Participants are randomly assigned to 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 on 4 chance that participants will be assigned to control group. Around 160 adult participants seeking correction of infraorbital hollowing will be enrolled at approximately 8 sites across China. Participants in treatment group will receive VOLBELLA with Lidocaine injections on Day 1 and followed for 12 months. Participants in control group are followed for 3 months. Participants in Control group can opt to receive VOLBELLA with Lidocaine injection after completion of 3 months and followed for 9 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

• Infraorbital Hollowing

Interventions

Type	Name	Description
DEVICE	VOLBELLA with Lidocaine	Facial Injection

Timeline

• Start date: 2021-10-19
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2021-10-22
• Last updated: 2024-11-25

Locations

7 sites across 1 country: China