NCT01998581

A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subjects Desiring Lip Augmentation

Interventions

Type	Name	Description
DEVICE	JUVEDERM VOLBELLA® XC	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.
DEVICE	Restylane-L®	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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-08-04
• Completion: 2015-05-29
• First posted: 2013-12-02
• Last updated: 2019-04-26
• Results posted: 2016-12-05

Locations

1 site across 1 country: United States