NCT00978042

Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.

Conditions

• Mid-facial Volume Deficit Related to Aging

Interventions

Type	Name	Description
DEVICE	Juvéderm® VOLUMA XC	Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-11-01
• Completion: 2014-04-01
• First posted: 2009-09-16
• Last updated: 2015-11-03
• Results posted: 2014-02-13

Locations

2 sites across 2 countries: United States, Canada