A multicenter, randomized, double-blind clinical study to evaluate the efficacy and safety of PP-501-B in correction of nasolabial folds.

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).

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.

Conclusions: 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.