CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
JUVEDERM VOLBELLA® XC +1 moredevice
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.

Search/NCT01998581
NCT01998581N/ACompleted
CompareCT.gov

A Multicenter, Double-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement

Allergan·interventional·Posted Dec 2, 2013·Updated Apr 26, 2019

In Brief

A clinical study evaluating JUVEDERM VOLBELLA® XC and Restylane-L® for Subjects Desiring Lip Augmentation. Completed, enrolled 225 participants across 1 site.

Detailed Summary

This is a multicenter, double-blind, randomized, controlled study of the safety and effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and perioral enhancement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubjects Desiring Lip Augmentation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2, 2013
Enrollment StartNov 1, 2013
Primary CompletionAug 4, 2014
Study CompletionMay 29, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.6 years ago

Interventions

JUVEDERM VOLBELLA® XCdevice

Up to 1.5 mL per lip (upper and lower) at each treatment (initial, touch-up, and repeat treatment). Additional product may be injected into the perioral area, as long as the total injection volume does not exceed 6.0 mL. Up to 6.0 mL allowed for repeat treatment.

Restylane-L®device

Up to 1.5 mL per lip (upper and lower) at each treatment (initial, touch-up, and repeat treatment). Additional product may be injected into the perioral area, as long as the total injection volume does not exceed 6.0 mL.. Up to 6.0 mL allowed for repeat treatment.