Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.

Abstract

Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition. To assess the efficacy and safety of ESTLF compared with RESL for the treatment of nasolabial folds (NLFs). In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to ESTLF on one side of the face and RESL on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance. The efficacy difference between ESTLF and RESL at M1 was in favor of ESTLF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for ESTLF, assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated. ESTLF is effective and well tolerated for the treatment of NLFs.