NCT00653861

Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Allergan Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.

Detailed description

Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	JUVÉDERM™ Injectable Gel with Lidocaine	Single treatment, volume determined by investigator
DEVICE	JUVÉDERM™ Injectable Gel	Single treatment, volume determined by investigator

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-06-01
• Completion: 2008-07-01
• First posted: 2008-04-07
• Last updated: 2014-10-13
• Results posted: 2009-12-30

Locations

1 site across 1 country: United States