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Case Reports
. 2019 Oct 24:12:791-798.
doi: 10.2147/CCID.S216222. eCollection 2019.

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

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 Marx  7
Affiliations
Case Reports

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

François Niforos et al. Clin Cosmet Investig Dermatol. .

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: Juvéderm Volite; hyaluronic acid; injectable dermal filler; skin aging.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Subject disposition. aSubjects who signed the informed consent form were considered enrolled. bIncluded in the primary effectiveness analysis. cThe denominator is the number of treated subjects (n=131). d3 subjects were lost to follow-up.
Figure 2
Figure 2
Allergan Skin Roughness Scale (ASRS) responder rates after treatment with VYC-12. The responder rate is the percentage of cheeks with ≥1-point improvement from baseline in cheek ASRS score based on the investigator’s assessment. Each cheek of the 131 treated subjects (261 treated cheeks) was rated separately. Abbreviations: CI, confidence interval; Month 1R, 1 month after repeat treatment.
Figure 3
Figure 3
Allergan Fine Lines Scale (AFLS) responder rate for VYC-12 treated cheeks with AFLS scores of 2 (moderate) or 3 (severe) at baseline. The responder rate is the percentage of cheeks with ≥1-point improvement from baseline in cheek AFLS score based on the investigator’s assessment. Abbreviations: CI, confidence interval; Month 1R, 1 month after repeat treatment.
Figure 4
Figure 4
Cheek skin hydration measured using the MoistureMeter D instrument. Increases indicate improved skin hydration. Month 1R=1 month after repeat treatment. aP<0.001. bP≤0.012. Paired t-test was used to test for mean changes from baseline.
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