FCT 2-8 : A clinical study of the efficacy and safety of injection with a polynucleotide filler in improvement of periorbital wrinkles

2018 
Background: The polynucleotide-containing products are widely used for aesthetic purposes, but their mechanism and efficacy haven’t been proved yet. Objectives: To evaluate the efficacy and safety of injection with Rejuran® (polynucleotide filler) in improvement of periorbital wrinkles (crow’s feet and infraorbital wrinkles). Methods: A total of 27 subjects with a lateral canthal line (LCL) severity score of more than 2 were enrolled in this randomized, matched pairs, active-controlled study. Each subject was injected three times in two-week intervals with Rejuran® in one periorbital wrinkle and a non-cross linked hyaluronic acid filler in the other. All subjects were evaluated for cosmetic changes at 10, 16 and 28 weeks after the first injection. The primary endpoint was the improvement of LCL score. Additionally, elasticity, hydration, roughness, pore size, and dermis density were evaluated. Results: The improvement rate of LCL was 37.04% at 16 weeks and it was maintained until 28 weeks (39.13%) after injection with Rejuran®. The improvement rate of hydration was 11.99% at 16 weeks and it was also maintained until 28 weeks (10.81%). The improvement rate of R2 was -1.12% at 16 weeks and it decreased to -4.41% at 28 weeks. No side effect was observed. Conclusion: This study supports the efficacy and safety of the polynucleotide filler in improvement of periorbital wrinkles.
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