Clinical, Cosmetic and Investigational Dermatology (Oct 2019)

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study

  • Niforos F,
  • Ogilvie P,
  • Cavallini M,
  • Leys C,
  • Chantrey J,
  • Safa M,
  • Abrams S,
  • Hopfinger R,
  • Marx A

Journal volume & issue
Vol. Volume 12
pp. 791 – 798

Abstract

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François Niforos,1 Patricia Ogilvie,2 Maurizio Cavallini,3 Christophe Leys,4 Jonquille Chantrey,5 Marva Safa,6 Steve Abrams,7 René Hopfinger,7 Ann Marx7 1Centre Chirurgical Niforos, Lyon, France; 2SkinConcept, Munich, Germany; 3Unit of Plastic Surgery, CDI Hospital, Milan, Italy; 4Medical Skincare, Sint-Truiden, Belgium; 5ØNE aesthetic studiø, Cheshire, UK; 6La Jouvence, Neuchâtel, Switzerland; 7Clinical Development, Allergan Plc, Irvine, CA, USACorrespondence: François NiforosCentre Chirurgical Niforos, 55 Boulevard Des Belges, Lyon 69006, FranceTel +33 4 78 93 95 55Fax +33 4 72 82 92 49Email [email protected]: Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection.Materials and methods: In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed.Results: Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate.Conclusion: VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.Keywords: hyaluronic acid, injectable dermal filler, Juvéderm Volite, skin aging

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