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

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.