CompletedNot Applicable

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

United States225 participantsStarted 2013-11-01

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 und…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, Month 3

Trial details

NCT IDNCT01998581

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08-04

Results submitted2016-07-26

View on ClinicalTrials.gov More Subjects Desiring Lip Augmentation trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.