NCT04594239

Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

* Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control. * Confirm the safety of BBL injection for the correction of volume loss in the IOH area.

Conditions

• Volume Loss in the Infraorbital Hollow Area

Interventions

Type	Name	Description
DEVICE	Belotero Balance (+) Lidocaine, needle	Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles
DEVICE	Belotero Balance (+) Lidocaine, cannula	Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas
DEVICE	Untreated-control / delayed-treatment, needle	Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)
DEVICE	Untreated-control / delayed-treatment, cannulas	Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)

Timeline

• Start date: 2020-08-31
• Primary completion: 2021-04-08
• Completion: 2022-06-21
• First posted: 2020-10-20
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

9 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study