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新型透明质酸真皮填充剂矫正鼻唇沟的疗效:一项前瞻性、对照、双盲临床试验。

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

机构信息

Eurofins-Dermscan, Villeurbanne, France.

Medical Practice, Lyon, France.

出版信息

Dermatol Surg. 2024 Aug 1;50(8):746-751. doi: 10.1097/DSS.0000000000004207. Epub 2024 May 7.

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).

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 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.

CONCLUSION

EST LF is effective and well tolerated for the treatment of NLFs.

摘要

背景

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。

目的

评估 EST LF 与 RES L 治疗鼻唇沟(NLFs)的疗效和安全性。

材料和方法

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。

结果

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。

结论

EST LF 治疗 NLFs 有效且耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba3f/11288387/89d6cdf4422e/ds-50-746-g001.jpg

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