Kim Jin-Su, In Chang-Hoon, Park Na-Jeong, Kim Beom Joon, Yoon Hye-Sung
Samyang Biopharmaceutical Corp. R&D Center, Seongnam, Korea.
Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.
J Cosmet Dermatol. 2020 Mar;19(3):596-604. doi: 10.1111/jocd.13076. Epub 2019 Jul 26.
In this study, a physical properties test and preclinical evaluation were performed on two polycaprolactone (PCL)-based dermal filler formulas.
This study was performed to compare the rheological characteristics, preclinical efficacy, and safety of a new PCL filler, SF-01, with a licensed PCL filler.
First, the viscoelasticity of the PCL filler was evaluated. Next, hairless mice were injected with fillers and evaluated for efficacy with a folliscope and PRIMOS . Histological evaluation was conducted for 6 months to evaluate safety.
In this evaluation, SF-01 was superior to a licensed PCL filler in initial volume increase rate and in vivo durability, and the migration of the injected filler was not confirmed. The elasticity (G*, G') and viscosity (G'') are also expected to be lower than those of a licensed PCL filler, thereby resulting in less foreign body sensation in the living body.
SF-01 (porous PCL microsphere-based dermal filler) has been confirmed to be superior in durability and shape retention compared to the licensed PCL filler (nonporous PCL microsphere-based dermal filler), and the in vivo safety is equivalent.
在本研究中，对两种基于聚己内酯（PCL）的真皮填充剂配方进行了物理性能测试和临床前评估。
本研究旨在比较新型PCL填充剂SF - 01与已获许可的PCL填充剂的流变学特性、临床前疗效和安全性。
首先，评估PCL填充剂的粘弹性。接下来，给无毛小鼠注射填充剂，并用毛囊镜和PRIMOS评估疗效。进行6个月的组织学评估以评估安全性。
在本次评估中，SF - 01在初始体积增加率和体内持久性方面优于已获许可的PCL填充剂，且未证实注射的填充剂有迁移现象。其弹性（G*，G'）和粘度（G''）预计也低于已获许可的PCL填充剂，从而在活体中产生较少的异物感。
已证实SF - 01（基于多孔PCL微球的真皮填充剂）在耐久性和形状保持方面优于已获许可的PCL填充剂（基于无孔PCL微球的真皮填充剂），且体内安全性相当。
