Clinical trial NCT01998581: A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement
Official title: A Multicenter, Double-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Desiring Lip Augmentation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 225
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: 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)
timeFrame: Baseline, Month 3
measure: Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: New Orleans
country: United States
state: Louisiana
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Geronemus RG, Bank DE, Hardas B, Shamban A, Weichman BM, Murphy DK. Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study. Dermatol Surg. 2017 Mar;43(3):396-404. doi: 10.1097/DSS.0000000000001035.