Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study.

BACKGROUND: VYC-15L (Juvederm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVE: To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA). METHODS: This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3. RESULTS: The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA. CONCLUSION: VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year. (C) 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.

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