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一项评估VYC-12L注射液对健康志愿者皮肤质量属性影响的前瞻性、开放标签研究。

A Prospective, Open-Label Study to Evaluate the Impact of VYC-12L Injection on Skin Quality Attributes in Healthy Volunteers.

作者信息

Safa Marva, Natalizio Audrey, Hee Christopher K

机构信息

La Jouvence, Neuchâtel, Switzerland.

Eurofins Dermscan Pharmascan, Villeurbanne, France.

出版信息

Clin Cosmet Investig Dermatol. 2022 Mar 10;15:411-426. doi: 10.2147/CCID.S352007. eCollection 2022.

DOI:10.2147/CCID.S352007
PMID:35300433
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8921677/
Abstract

PURPOSE

Age-related changes in skin structure and function can negatively impact skin quality. VYC-12L is a crosslinked hyaluronic acid filler for treating fine lines and improving hydration and elasticity. The goal of this study was to understand skin quality, histologic, and genomic changes underlying long-term clinical benefits of VYC-12L treatment.

PATIENTS AND METHODS

In this prospective, nonrandomized, open-label study, 11 healthy men (n = 2) and women (n = 9) received intradermal VYC-12L treatment on the volar forearm. Clinical probes assessed skin quality at baseline and months 1 and 3 post-treatment. Punch biopsies were collected 1 and 3 months post-treatment to evaluate histologic and genomic changes. Safety was evaluated throughout.

RESULTS

Participants had a mean age of 41 years and Fitzpatrick skin phototypes II (54.5%) and III (45.5%). At months 1 and 3, VYC-12L-treated skin had higher hydration in the stratum corneum than untreated skin. Cutometer measurements indicated treated skin that was firmer and more resistant to deformation. Histology showed increased epidermal AQP3 and Ki67 expression 1 and 3 months post-treatment and a qualitative increase in papillary dermal collagen I at month 3. Genomic analyses demonstrated treatment-related upregulation of genes involved in adipocyte differentiation, lipid metabolism, keratinocyte renewal, and dermal extracellular matrix (ECM) maintenance. Injection site reactions were mild-to-moderate in severity and resolved by month 1. Five participants reported 19 adverse events; most (68.4%) were related to the biopsy and none to VYC-12L.

CONCLUSION

VYC-12L produced changes in hydration, firmness, and ECM density and composition consistent with improved skin properties, demonstrating that VYC-12L can act as a substrate for tissue repair.

摘要

目的

皮肤结构和功能的年龄相关性变化会对皮肤质量产生负面影响。VYC - 12L是一种用于治疗细纹以及改善皮肤水合作用和弹性的交联透明质酸填充剂。本研究的目的是了解VYC - 12L治疗长期临床益处背后的皮肤质量、组织学和基因组变化。

患者和方法

在这项前瞻性、非随机、开放标签研究中,11名健康男性(n = 2)和女性(n = 9)在前臂掌侧接受了皮内VYC - 12L治疗。临床探头在基线以及治疗后1个月和3个月评估皮肤质量。在治疗后1个月和3个月采集打孔活检样本,以评估组织学和基因组变化。全程评估安全性。

结果

参与者的平均年龄为41岁,皮肤光类型为Fitzpatrick II型(54.5%)和III型(45.5%)。在治疗后1个月和3个月,接受VYC - 12L治疗的皮肤角质层水合作用高于未治疗的皮肤。皮肤弹性测定仪测量表明,治疗后的皮肤更紧致且更抗变形。组织学显示,治疗后1个月和3个月表皮水通道蛋白3(AQP3)和Ki67表达增加,且在治疗后3个月乳头层真皮胶原蛋白I有定性增加。基因组分析表明,与治疗相关的基因上调涉及脂肪细胞分化、脂质代谢、角质形成细胞更新和真皮细胞外基质(ECM)维持。注射部位反应的严重程度为轻度至中度,在1个月时消退。5名参与者报告了19起不良事件;大多数(68.4%)与活检有关,与VYC - 12L无关。

结论

VYC - 12L在水合作用、紧致度以及ECM密度和组成方面产生了与改善皮肤特性一致的变化,表明VYC - 12L可作为组织修复的底物。

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