PDF(Pubmed)
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 EST LF compared with RES L for the treatment of nasolabial folds (NLFs).
METHODS: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L 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 EST LF and RES L at M1 was in favor of EST LF (-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 EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated.
CONCLUSIONS: EST LF is effective and well tolerated for the treatment of NLFs.
OBJECTIVE: To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs).
METHODS: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L 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 EST LF and RES L at M1 was in favor of EST LF (-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 EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated.
CONCLUSIONS: EST LF is effective and well tolerated for the treatment of NLFs.
摘要：
背景：基于透明质酸的真皮填充物是皱纹矫正和面部轮廓重新定义的基石。
目的：评估ESTLF与RESL治疗鼻唇沟（NLF）的疗效和安全性。
方法：在此前瞻性中，分割面,随机化，研究者和受试者盲化试验，45名具有中度至重度对称NLF的受试者随机分为面部一侧的ESTLF和另一侧的RESL，并随访9个月。主要终点是WSRS评分从基线到第1个月(M1)的变化。次要终点包括其他时间点WSRS评分的变化，美学改进，皱纹体积定量，不良事件,当地的宽容。
结果：M1时ESTLF和RESL之间的疗效差异有利于ESTLF（-0.16，CI，-0.28至-0.03]），证明了它的非劣性。考虑到其他时间点，ESTLF在3个月和6个月时观察到显著差异，与WSRS评估，盖斯,或NLF体积定量。两种治疗均耐受良好。
结论：ESTLF治疗NLF有效且耐受性良好。
目的：评估ESTLF与RESL治疗鼻唇沟（NLF）的疗效和安全性。
方法：在此前瞻性中，分割面,随机化，研究者和受试者盲化试验，45名具有中度至重度对称NLF的受试者随机分为面部一侧的ESTLF和另一侧的RESL，并随访9个月。主要终点是WSRS评分从基线到第1个月(M1)的变化。次要终点包括其他时间点WSRS评分的变化，美学改进，皱纹体积定量，不良事件,当地的宽容。
结果：M1时ESTLF和RESL之间的疗效差异有利于ESTLF（-0.16，CI，-0.28至-0.03]），证明了它的非劣性。考虑到其他时间点，ESTLF在3个月和6个月时观察到显著差异，与WSRS评估，盖斯,或NLF体积定量。两种治疗均耐受良好。
结论：ESTLF治疗NLF有效且耐受性良好。
