Eurofins-Dermscan, Villeurbanne, France.
Medical Practice, Lyon, France.
Dermatol Surg. 2024 Aug 1;50(8):746-751. doi: 10.1097/DSS.0000000000004207. Epub 2024 May 7.
Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition.
To assess the efficacy and safety of EST LF compared with RES L 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 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.
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.
EST LF is effective and well tolerated for the treatment of NLFs.
透明质酸基真皮填充剂是纠正皱纹和重塑面部轮廓的基石。
评估 EST LF 与 RES L 治疗鼻唇沟（NLFs）的疗效和安全性。
在这项前瞻性、分面、随机、研究者和受试者双盲试验中，45 名患有中重度对称 NLFs 的受试者被随机分配到面部一侧接受 EST LF，另一侧接受 RES L，并随访 9 个月。主要终点是从基线到第 1 个月（M1）WSRS 评分的变化。次要终点包括其他时间点 WSRS 评分的变化、美学改善、皱纹体积量化、不良事件和局部耐受性。
EST LF 和 RES L 在 M1 时的疗效差异有利于 EST LF（-0.16，CI，-0.28 至-0.03]），表明其非劣效性。考虑到其他时间点，EST LF 在 3 个月和 6 个月时在 WSRS、GAIS 或 NLF 体积量化评估时，差异具有统计学意义。两种治疗方法均具有良好的耐受性。
EST LF 治疗 NLFs 有效且耐受性良好。
