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

Allergan0 sites225 target enrollmentNovember 1, 2013

ConditionsSubjects Desiring Lip Augmentation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Subjects Desiring Lip Augmentation
Sponsor: Allergan
Enrollment: 225
Primary Endpoint: Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2013

End Date

May 29, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•22 years of age or older
•Has a score of minimal, mild, or moderate on the LFS2, as agreed upon by the Treating and Evaluating Investigators, and desires at least 1 point of correction for one or both lips
•For treatment of perioral lines, has a POLSS score of severe or moderate as agreed upon by the Treating and Evaluating Investigators (all subjects are eligible for treatment in the vermilion body, oral commissures, vermilion border, Cupid's bow, and philtral columns)

Exclusion Criteria

•Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
•Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator
•Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
•Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
•Has undergone semipermanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment or is planning to undergo such treatment during the study
•Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study
•Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the lower face (below the orbital rim) within 6 months before enrollment or is planning to undergo any of these procedures during the study

Outcomes

Primary Outcomes

Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale

Time Frame: Baseline, Month 3

Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.

Secondary Outcomes

Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire(Baseline, Month 3)
Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)(Baseline, Month 3)