NCT01197495

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.

Conditions

• Lip Augmentation

Interventions

Type	Name	Description
DEVICE	hyaluronic acid gel	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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-06-19
• Completion: 2015-06-15
• First posted: 2010-09-09
• Last updated: 2019-04-16
• Results posted: 2016-06-07

Locations

1 site across 1 country: United States