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

Abstract

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

Acknowledgments

This study was funded by Allergan plc. Medical writing and editorial support for this article were provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, New Jersey, and was funded by Allergan plc.

Abbreviations

AEs, adverse events; AFLS, Allergan Fine Lines Scale; ASRS, Allergan Skin Roughness Scale; CI, confidence interval; HA, hyaluronic acid; ISRs, injection site responses.

Data Sharing Statement

Data reported in this manuscript are available within the article [and/or] its supplementary tables. Allergan will share de-identified patient-level data and/or study-level data, including protocols and clinical study reports, for phase 2-4 trials completed after 2008 that are registered on ClinicalTrials.gov or EudraCT. The indication studied in the trial must have regulatory approval in the United States and/or the European Union and the primary manuscript from the trial must be published prior to data sharing. To request access to the data, the researcher must sign a data use agreement. All shared data are to be used for non-commercial purposes only. More information can be found on http://www.allerganclinicaltrials.com/.

Disclosure

F. Niforos, C. Leys, M. Cavallini, P. Ogilvie, M. Safa, and J. Chantrey are investigators for Allergan plc, Marlow, UK. J. Chantrey reports personal fee from Allergan as a teaching consultant, during the conduct of the study and outside the submitted work. A. Marx and S. Abrams are employees of Allergan plc, Irvine, CA. R. Hopfinger was an employee of Allergan plc, Irvine, CA at the time of this study. The authors report no other conflicts of interest in this work.