PDF(Pubmed)
Abstract：
Dermal filler injectability is a critical factor for commercial product adoption by medical aesthetic professionals and for successful clinical administration. We have previously reported (in vitro and ex vivo) cross-linked hyaluronic acid (HA)-based dermal filler benchmarking in terms of manual and automated injectability requirements. To further enhance the function-oriented product characterization workflows and the clinical relevance of dermal filler injectability assessments, the aim of this study was to perform in vivo evaluations. Therefore, several variants of the MaiLi® product range (OxiFree™ technology) were characterized in vitro and in vivo in terms of injectability attributes, with a focus on hydrogel system homogeneity and ease of injection. Firstly, standardized in vitro assays were performed in SimSkin® cutaneous equivalents, with variations of the clinical injector, injection site, and injection technique. Then, automated injections in SimSkin® cutaneous equivalents were comparatively performed in a texture analysis setup to obtain fine-granulometry injection force profile results. Finally, five female participants were recruited for the in vivo arm of the study (case reports), with variations of the clinical injector, injection site, and injection technique. Generally, the obtained quantitative force values and injection force profiles were critically appraised from a translational viewpoint, based on discussions around the OxiFree™ manufacturing technology and on in-use specialized clinician feedback. Overall, the present study outlined a notable level of homogeneity across the MaiLi® product range in terms of injectability attributes, as well as consistently high ease of administration by medical aesthetic clinicians.
摘要：
真皮填充剂可注射性是医学美容专业人员采用商业产品和成功的临床施用的关键因素。我们先前已经报道了(体外和离体)基于交联透明质酸(HA)的真皮填充剂在手动和自动可注射性要求方面的基准。为了进一步增强面向功能的产品表征工作流程和真皮填充剂可注射性评估的临床相关性，本研究的目的是进行体内评估.因此,MaiLi®产品系列（OxiFree™技术）的几种变体在体外和体内的可注射性属性方面进行了表征，重点是水凝胶系统的均匀性和易于注射。首先,在SimSkin®皮肤等效物中进行标准化的体外测定，随着临床注射器的变化，注射部位,注射技术。然后，在质地分析装置中比较地进行了SimSkin®皮肤等效物中的自动注射,以获得细粒度注射力曲线结果.最后,招募了五名女性参与者参与研究的体内研究（病例报告），随着临床注射器的变化，注射部位,注射技术。一般来说,从平移的角度对获得的定量力值和注射力曲线进行了严格评估，基于围绕OxiFree™制造技术的讨论和使用中的专业临床医生反馈。总的来说,本研究概述了MaiLi®产品系列在可注射性属性方面的显著同质性，以及医疗美容临床医生一贯高度的管理。
