At a glance
ClinicalIndex Comparison RecordN/ACompleted· 209 enrolled
Drug / intervention
JUVÉDERM VOLITE™ 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.
Protocol Title: A Randomized, Multicenter, Evaluator-blind, Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLITE™ XC Injectable Gel for the Improvement in Cheek Skin Smoothness
In Brief
A clinical study evaluating JUVÉDERM VOLITE™ XC for Skin Smoothness of the Cheeks. Completed, enrolled 209 participants across 14 sites in 2 countries.
Detailed Summary
This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Smoothness of the Cheeks
CountriesPuerto Rico, United States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartNov 2018
Primary CompletionJul 2020
TodayJul 2026
First PostedNov 2, 2018
Enrollment StartNov 9, 2018
Primary CompletionJul 17, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.7 years ago
Interventions
JUVÉDERM VOLITE™ XCdevice
Intradermal, needle in multiple microdepot injections across both cheeks.