CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 213 enrolled
Drug / intervention
hyaluronic acid geldevice
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/NCT01197495
NCT01197495N/ACompleted

Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation

Allergan·interventional·Posted Sep 9, 2010·Updated Apr 16, 2019

In Brief

A clinical study evaluating hyaluronic acid gel for Lip Augmentation. Completed, enrolled 213 participants across 1 site.

Detailed Summary

The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2010
Enrollment StartAug 1, 2010
Primary CompletionJun 19, 2014
Study CompletionJun 15, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.8 years ago

Interventions

hyaluronic acid geldevice

Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.