VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study
Received 18 May 2019
Accepted for publication 29 September 2019
Published 24 October 2019 Volume 2019:12 Pages 791—798
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Jeffrey Weinberg
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, USA
Correspondence: François Niforos
Centre Chirurgical Niforos, 55 Boulevard Des Belges, Lyon 69006, France
Tel +33 4 78 93 95 55
Fax +33 4 72 82 92 49
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.
Keywords: hyaluronic acid, injectable dermal filler, Juvéderm Volite, skin aging
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