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

Abstract

BACKGROUND Hyaluronic acid–based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition. OBJECTIVE To assess the efficacy and safety of ESTLF compared with RESL for the treatment of nasolabial folds (NLFs). MATERIALS AND METHODS 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. RESULTS 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. CONCLUSION ESTLF is effective and well tolerated for the treatment of NLFs.