A Safety and Effectiveness Study of JUV… | Clinical Trial

Key information

Conditions

Subjects Desiring Lip Augmentation

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Orleans, Louisiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JUVEDERM VOLBELLA® XC

Device

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.

Restylane-L®

Device

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.

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

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)

Time frame: Baseline, Month 3

The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.
Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire

Time frame: Baseline, Month 3

Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Dec 2, 2013
Registry last updated: Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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