Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study

BACKGROUND Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform. OBJECTIVE To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate to severe nasolabial folds (NLFs) compared with a control HA dermal filler. METHODS In this double-blind study, 123 adults with 2 moderate or severe NLFs as measured on the 5-point photonumeric NLF severity scale (NLFSS) were randomized to VYC-17.5L in 1 NLF and control in the contralateral NLF. The coprimary effectiveness end points at Month 6 were difference in improvement in mean NLFSS score for VYC-17.5L versus control and NLFSS responder rate (≥1-point improvement) for VYC-17.5L. RESULTS The coprimary effectiveness end points were met. NLFSS scores improved by 1.4 with VYC-17.5L and by 1.3 with control; NLFSS responder rate with VYC-17.5L was 93.2%. More than three-quarters of subjects (82%) treated with VYC-17.5L were very satisfied at Month 6. Investigators reported that VYC-17.5L was smoother and more natural looking and easier to inject and mold than control. VYC-17.5L resulted in significantly fewer severe injection site responses than control. CONCLUSION VYC-17.5L was safe and effective for correcting moderate to severe NLFs, with results lasting through 6 months in 93% of subjects. Address correspondence and reprint requests to: Gary Monheit, MD, Total Skin and Beauty Dermatology Center, 2100 16th Avenue South, Suite 202, Birmingham, AL 35205, or e-mail: gdmonheit@gmail.com This study was funded by Allergan plc, Dublin, Ireland. Editorial support for this article was provided by Peloton Advantage, Parsippany, New Jersey, and was funded by Allergan plc. G. Monheit is an investigator for Allergan plc, Galderma, Alphaeon, and Teoxane and is a consultant for Allergan plc, Galderma, Suneva, and Merz. K. Beer is a clinical trial investigator, consultant, and speaker for Allergan plc, Galderma, and Merz. He is a shareholder in Anterios and a partner in The Cosmetic Bootcamp and Theraplex LLC. P.E. Grimes is an investigator for Allergan plc, Suneva, and Alphaeon, and is a consultant for Procter & Gamble. B. Hardas, V. Lin, and D.K. Murphy were employees and stockholders of Allergan plc at the time of the study. B.M. Weichman provided medical writing assistance at the request of the authors, which was funded by Allergan plc. © 2018 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.

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