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A multicenter, randomized, double-blind clinical study to evaluate the efficacy and safety of PP-501-B as compared to restylane perlane® in correction of nasolabial fold
( Joon Seok ) , ( In Kwon Yeo ) , ( Kui Young Park ) , ( Seong Jun Seo ) , ( Myeung Nam Kim ) , ( Sung Eun Chang ) , ( Chong Hyun Won ) , ( Yang Won Lee )
프로그램북 66권 2호 363-364(2pages)
UCI I410-ECN-0102-2015-500-000178276
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Background: Hyaluronic acid(HA) fillers have become popular soft tissue filler augmentation agents over the past several years. Many new brands of HA fillers are being produced, but comparative research on the characteristics of similar products is limited. Objectives: The purpose of this study was to test the efficacy, tolerability, and safety of a new HA filler, PP-501-B (Cleviel contour®, Pacific pharm., Korea) which is used for correcting nasolabial folds (NLFs), and compare PP-501-B with Restylane Perlane® (Q-Med, Uppsala, Sweden). Methods: One hundred three subjects with visible NLFs were enrolled in a randomized, multi-center, patient & evaluator-blind, active-controlled, matched-pair clinical study. Each subject was injected with PP-501-B in one NLF and Restylane Perlane® in the other. All participants were then reassessed for cosmetic change at 8, 16, and 24 weeks. Wrinkle severity was rated using the 5-point wrinkle severity rating scale (WSRS) Results: At week 24, the mean improvement in the WSRS from baseline was 1.87 ± 0.73 for the PP-501-B side and 1.92 ± 0.71 for the Restylane Perlane®. Both fillers were well-tolerated and adverse reactions were mild and transient in most cases. Conclusion: The addition of a new HA filler, PP-501-B with suitable characteristics and ample safety profiles to the market will widen the selection for physicians and patients because the purpose, area, and depth of filler injections are variable by treatment.

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