Dataset Information

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

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.

SUBMITTER: Monheit G

PROVIDER: S-EPMC6221389 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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

Monheit Gary G Beer Kenneth K Hardas Bhushan B Grimes Pearl E PE Weichman Barry M BM Lin Vince V Murphy Diane K DK

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] 20180501 5

<h4>Background</h4>Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform.<h4>Objective</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 29701621

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Project description:Introduction: The lips and the mouth play an indispensable role in vocalization, mastication and face aesthetics. Various noxious factors may alter and destruct the original structure, and appearance of the lips and the anatomical area surrounding the mouth. The application of hyaluronic acid (HA) may serve as a safe method for lip regeneration. Although a number of studies exist for HA effectiveness and safety, its beneficial effect is not well-established. Aim: The present meta-analysis and systematic review was performed to investigate the effectiveness of HA on lip augmentation. We also investigated the types and nature of adverse effects (AEs) of HA application. Methods: We reported our meta-analysis in accordance with the PRISMA Statement. PROSPERO protocol registration: CRD42018102899. We performed the systematic literature search in CENTRAL, Embase, and MEDLINE. Randomized controlled trials, cohort studies, case series and case reports were included. The untransformed proportion (random-effects, DerSimonian-Laird method) of responder rate to HA injection was calculated. For treatment related AEs descriptive statistics were used. Results: The systematic literature search yielded 32 eligible records for descriptive statistics and 10 records for quantitative synthesis. The results indicated that the overall estimate of responders (percentage of subjects with increased lip fullness by one point or higher) was 91% (ES = 0.91, 95% CI:0.85-0.96) 2 months after injection. The rate of responders was 74% (ES = 0.74, 95% CI:0.66-0.82) and 46% (ES = 0.46, 95% CI:0.28-0.65) after 6 and 12 months, respectively. We included 1,496 participants for estimating the event rates of AEs. The most frequent treatment-related AEs were tenderness (88.8%), injection site swelling (74.3%) and bruising (39.5%). Rare AEs included foreign body granulomas (0.6%), herpes labialis (0.6%) and angioedema (0.3%). Conclusion: Our meta-analysis revealed that lip augmentation with injectable HA is an efficient method for increasing lip fullness for at least up to 6 months after augmentation. Moreover, we found that most AEs of HA treatment were mild or moderate, but a small number of serious adverse effects were also found. In conclusion, further well-designed RCTs are still needed to make the presently available evidence stronger.

Dataset Information

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

Publications

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

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