Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study

Gary Monheit, Kenneth Beer, Bhushan Hardas, Pearl E Grimes, Barry M Weichman, Vince Lin, Diane K Murphy, Gary Monheit, Kenneth Beer, Bhushan Hardas, Pearl E Grimes, Barry M Weichman, Vince Lin, Diane K Murphy

Abstract

Background: Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform.

Objective: To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate to severe nasolabial folds (NLFs) compared with a control HA dermal filler.

Methods: In this double-blind study, 123 adults with 2 moderate or severe NLFs as measured on the 5-point photonumeric NLF severity scale (NLFSS) were randomized to VYC-17.5L in 1 NLF and control in the contralateral NLF. The coprimary effectiveness end points at Month 6 were difference in improvement in mean NLFSS score for VYC-17.5L versus control and NLFSS responder rate (≥1-point improvement) for VYC-17.5L.

Results: The coprimary effectiveness end points were met. NLFSS scores improved by 1.4 with VYC-17.5L and by 1.3 with control; NLFSS responder rate with VYC-17.5L was 93.2%. More than three-quarters of subjects (82%) treated with VYC-17.5L were very satisfied at Month 6. Investigators reported that VYC-17.5L was smoother and more natural looking and easier to inject and mold than control. VYC-17.5L resulted in significantly fewer severe injection site responses than control.

Conclusion: VYC-17.5L was safe and effective for correcting moderate to severe NLFs, with results lasting through 6 months in 93% of subjects.

Figures

Figure 1.
Figure 1.
Representative photographs of a subject's NLFs at baseline and Month 6. EI, evaluating investigator; NLFs, nasolabial folds.
Figure 2.
Figure 2.
Nasolabial Fold Severity Scale responder rates based on EI assessment after treatment with VYC-17.5L and control by study visit. EI, evaluating investigator; NLFSS, Nasolabial Fold Severity Scale.
Figure 3.
Figure 3.
Overall appraisal of NLF FACE-Q score after treatment with VYC-17.5L and control by study visit. *Subject responses to the 5 FACE-Q questions were combined into an overall score for the NLF ranging from 0 (subject is extremely bothered by appearance of the NLF) to 100 (subject is not at all bothered by the appearance of the NLF) using the scale developers' scoring algorithm. NLF, nasolabial fold.
Figure 4.
Figure 4.
Evaluating investigator assessments of natural look, by visit.
Figure 5.
Figure 5.
Subject satisfaction with treatment. *Shown are the percentage of subjects with scores of 7 through 10 on an 11-point scale (0 = completely dissatisfied; 10 = completely satisfied).

References

    1. Gierloff M, Stohring C, Buder T, Gassling V, et al. Aging changes of the midfacial fat compartments: a computed tomographic study. Plast Reconstr Surg 2012;129:263–73.
    1. Le Louarn C, Buthiau D, Buis J. Structural aging: the facial recurve concept. Aesthet Plast Surg 2007;31:213–8.
    1. Ezure T, Amano S. Involvement of upper cheek sagging in nasolabial fold formation. Skin Res Technol 2012;18:259–64.
    1. Beasley KL, Weiss MA, Weiss RA. Hyaluronic acid fillers: a comprehensive review. Facial Plast Surg 2009;25:86–94.
    1. Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, et al. Appropriate selection and application of nonsurgical facial rejuvenation agents and procedures: panel consensus recommendations. Aesthet Surg J 2010;30(Suppl1):36S–45S.
    1. Eccleston D, Murphy DK. Juvéderm (R) Volbella in the perioral area: a 12-month prospective, multicenter, open-label study. Clin Cosmet Investig Dermatol 2012;5:167–72.
    1. Raspaldo H, De Boulle K, Levy PM. Longevity of effects of hyaluronic acid plus lidocaine facial filler. J Cosmet Dermatol 2010;9:11–5.
    1. Gassia V, Raspaldo H, Niforos FR, Michaud T. Global 3-dimensional approach to natural rejuvenation: recommendations for perioral, nose, and ear rejuvenation. J Cosmet Dermatol 2013;12:123–36.
    1. Baumann LS, Shamban AT, Lupo MP, Monheit GD, et al. Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study. Dermatol Surg 2007;33(Suppl 2):S128–35.
    1. Pinsky MA, Thomas JA, Murphy DK, Walker PS. Juvéderm injectable gel: a multicenter, double-blind, randomized study of safety and effectiveness. Aesthet Surg J 2008;28:17–23.
    1. Lupo MP, Smith SR, Thomas JA, Murphy DK, et al. Effectiveness of Juvederm Ultra Plus dermal filler in the treatment of severe nasolabial folds. Plast Reconstr Surg 2008;121:289–97.
    1. Grimes PE, Thomas JA, Murphy DK. Safety and effectiveness of hyaluronic acid fillers in skin of color. J Cosmet Dermatol 2009;8:162–8.
    1. Smith SR, Jones D, Thomas JA, Murphy DK, et al. Duration of wrinkle correction following repeat treatment with Juvederm hyaluronic acid fillers. Arch Dermatol Res 2010;302:757–62.
    1. Weinkle SH, Bank DE, Boyd CM, Gold MH, et al. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine. J Cosmet Dermatol 2009;8:205–10.
    1. Nast A, Reytan N, Hartmann V, Pathirana D, et al. Efficacy and durability of two hyaluronic acid-based fillers in the correction of nasolabial folds: results of a prospective, randomized, double-blind, actively controlled clinical pilot study. Dermatol Surg 2011;37:768–75.
    1. Rzany B, Bayerl C, Bodokh I, Boineau D, et al. Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of moderate nasolabial folds: 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Laser Ther 2011;13:107–12.
    1. Wu Y, Xu J, Jia Y, Murphy DK. Safety and effectiveness of hyaluronic acid injectable gel in correcting moderate nasolabial folds in Chinese subjects. J Drugs Dermatol 2016;15:70–6.
    1. Ascher B, Bayerl C, Brun P, Kestemont P, et al. Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Dermatol 2011;10:94–8.

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