Ccid_a_216222 791..798

François Niforos Patricia Ogilvie 2 Maurizio Cavallini Christophe Leys Jonquille Chantrey Marva Safa 6 Steve Abrams René Hopfinger 7 Ann Marx 1Centre Chirurgical Niforos, Lyon, France; 2SkinConcept, Munich, Germany; 3Unit of Plastic Surgery, CDI Hospital, Milan, Italy; 4Medical Skincare, SintTruiden, Belgium; 5ØNE aesthetic studiø, Cheshire, UK; 6La Jouvence, Neuchâtel, Switzerland; 7Clinical Development, Allergan Plc, Irvine, CA, USA Objective: 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.