At a glance
ClinicalIndex Comparison RecordN/ACompleted· 345 enrolled
Drug / intervention
Juvéderm® VOLUMA XCdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
In Brief
A clinical study evaluating Juvéderm® VOLUMA XC for Mid-facial Volume Deficit Related to Aging. Completed, enrolled 345 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionNov 2012
Study CompletionApr 2014
TodayJul 2026
First PostedSep 16, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2012
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.8 years ago
Interventions
Juvéderm® VOLUMA XCdevice
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.