MedTrace Logo

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

NCT01998581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2019-04-26

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2014-08-04
Completion
2015-05-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01998581 on ClinicalTrials.gov