PDF(Pubmed)
Abstract：
Hyaluronic acid (HA) hydrogels are commonly used for facial dermal filling and for alternative medical aesthetic purposes. High diversity exists in commercial formulations, notably for the optimization of finished product stability, functionality, and performance. Polyvalent ingredients such as calcium hydroxylapatite (CaHA) or vitamin B3 (niacinamide) are notably used as bio-stimulants to improve skin quality attributes at the administration site. The aim of the present study was to perform multi-parametric characterization of two novel cross-linked dermal filler formulas (HAR-1 \"Instant Refine\" and HAR-3 \"Maxi Lift\") for elucidation of the various functional impacts of vitamin B3 incorporation. Therefore, the HAR products were firstly comparatively characterized in terms of in vitro rheology, cohesivity, injectability, and resistance to chemical or enzymatic degradation (exposition to H2O2, AAPH, hyaluronidases, or xanthine oxidase). Then, the HAR products were assessed for cytocompatibility and in vitro bio-stimulation attributes in a primary dermal fibroblast model. The results showed enhanced resilience of the cohesive HAR hydrogels as compared to JUVÉDERM® VOLBELLA® and VOLUMA® reference products in a controlled degradation assay panel. Furthermore, significant induction of total collagen synthesis in primary dermal fibroblast cultures was recorded for HAR-1 and HAR-3, denoting intrinsic bio-stimulatory effects comparable or superior to those of the Radiesse® and Sculptra™ reference products. Original results of high translational relevance were generated herein using robust and orthogonal experimental methodologies (hydrogel degradation, functional benchmarking) and study designs. Overall, the reported results confirmed the dual functionalization role of vitamin B3 in cross-linked HA dermal fillers, with a significant enhancement of hydrogel system stability attributes and the deployment of potent bio-stimulatory capacities.
摘要：
透明质酸(HA)水凝胶通常用于面部真皮填充和用于替代医学美学目的。商业配方中存在高度多样性，特别是对于成品稳定性的优化，功能，和性能。多价成分如羟基磷灰石钙(CaHA)或维生素B3(烟酰胺)值得注意地用作生物刺激剂以改善施用部位的皮肤质量属性。本研究的目的是对两种新型交联真皮填充剂配方（HAR-1“InstantRefine”和HAR-3“MaxiLift”）进行多参数表征，以阐明维生素B3掺入的各种功能影响。因此,首先在体外流变学方面对HAR产品进行了比较表征，粘结性,可注射性,和对化学或酶降解的抗性(暴露于H2O2、AAPH、透明质酸酶,或黄嘌呤氧化酶)。然后，在原代真皮成纤维细胞模型中评估HAR产品的细胞相容性和体外生物刺激属性.结果显示,在受控降解测定面板中,与JUV_DERM®VOLBELLA®和VOLUMA®参考产品相比,粘性HAR水凝胶的弹性增强。此外，对于HAR-1和HAR-3,记录了初级真皮成纤维细胞培养物中总胶原合成的显著诱导,表明固有生物刺激效应与Radiesse®和Sculptra™参考产品相当或优于这些。本文使用稳健和正交实验方法（水凝胶降解，功能基准)和研究设计。总的来说,报告的结果证实了维生素B3在交联HA真皮填充剂中的双重功能化作用，具有水凝胶系统稳定性属性的显着增强和有效的生物刺激能力的部署。
