A Randomized, Participant- and Evaluator-Blinded, Matched-Pair, Prospective Study Comparing the Safety and Efficacy Between Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet.

Abstract

Background: Dermal fillers have gained widespread popularity for facial cosmetic enhancement and anti-aging treatments. Recently, polycaprolactone (PCL) and polynucleotides (PN) fillers have emerged as promising options owing to their safety and long-lasting effects.

Objectives: This study aimed to compare the efficacy and safety of a novel PCL-based dermal filler (DLMR01) with purified PN filler (RJR: Rejuran) in correcting crow's feet wrinkles.

Materials and methods: A randomized, evaluator-blinded, prospective split-face study was conducted with 218 healthy Asian participants. The primary outcome was in the improvement rate of the Crow's Feet Grading Scale (CFGS) at rest after 12 weeks. Secondary outcomes included the improvement rate of the CFGS at expression and rest at earlier time points, changes in CFGS, and the Global Aesthetic Improvement Scale (GAIS) assessment.

Results: The results showed that DLMR01 was not inferior to RJR in improving crow's feet wrinkles, with a significantly higher CGFS improvement rate at week 12. Both fillers demonstrated good safety profiles, with mild and tolerable adverse events. No serious adverse events were reported during the study period.

Conclusion: DLMR01, a pegylated PCL-based dermal filler, showed effectiveness and safety in improving wrinkles described as crow's feet. The study suggests that DLMR01 could be a promising option for noninvasive anti-aging treatments.