ABSTRACT
BACKGROUND: In this study, a physical properties test and preclinical evaluation were performed on two polycaprolactone (PCL)-based dermal filler formulas. OBJECTIVE: 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. METHODS: First, the viscoelasticity of the PCL filler was evaluated. Next, hairless mice were injected with fillers and evaluated for efficacy with a folliscope and PRIMOSLITE . Histological evaluation was conducted for 6 months to evaluate safety. RESULTS: 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. CONCLUSION: 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.