A Multicenter, Randomized, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of PP-501-B in Correction of Nasolabial Folds

Abstract

BACKGROUND Many new brands of hyaluronic acid (HA) fillers are being produced, but comparative research on the characteristics of similar products is limited. OBJECTIVE To test the efficacy, tolerability, and safety of a new HA filler, PP-501-B (Cleviel Contour; Pacific Pharma, Seoul, Korea), which is used for correcting nasolabial folds (NLFs), and to compare the performance of PP-501-B with that of Restylane Perlane (Q-Med). MATERIALS AND METHODS A total of 103 subjects with visible NLFs were enrolled in this randomized, multicenter, patient/evaluator-blind, active-controlled, matched-pair clinical study. Each subject was injected with PP-501-B in 1 NLF and Restylane Perlane in the other. All participants were reassessed for cosmetic changes 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 compared with baseline was 1.87 +/- 0.73 for the PP-501-B side and 1.92 +/- 0.71 for the Restylane Perlane side. Both fillers were well tolerated, and adverse reactions were mild. CONCLUSION The new HA filler, PP-501-B, to the market, with suitable characteristics and ample safety profiles, will widen the selection of agents for physicians and patients because the purpose, area, and depth of filler injections vary.