新型透明质酸皮肤填充剂对鼻唇沟矫正的功效:前瞻性、对比性、双盲临床试验。

IF 2.5 3区 医学 Q2 DERMATOLOGY Dermatologic Surgery Pub Date : 2024-08-01 Epub Date: 2024-05-07 DOI:10.1097/DSS.0000000000004207
Céline Lheritier, Sophie Converset, Berthold-Josef Rzany, Hugues Cartier, Benjamin Ascher
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引用次数: 0

摘要

背景:基于透明质酸的皮肤填充剂是除皱和面部轮廓重塑的基石:透明质酸类皮肤填充剂是皱纹矫正和面部轮廓重塑的基石:评估ESTLF与RESL治疗鼻唇沟(NLF)的有效性和安全性:在这项前瞻性、分面、随机、研究者和受试者双盲的试验中,45 名患有中度至重度对称性鼻唇沟的受试者被随机分配接受一侧面部的 ESTLF 和另一侧面部的 RESL 治疗,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的 WSRS 评分变化、美学改善、皱纹体积量化、不良事件和局部耐受性:ESTLF和RESL在第1个月的疗效差异为ESTLF(-0.16,CI,-0.28至-0.03]),表明其无劣势。考虑到其他时间点,根据WSRS、GAIS或NLF体积量化评估,ESTLF在3个月和6个月时有显著差异。两种治疗方法的耐受性均良好:结论:ESTLF 治疗 NLF 效果显著,耐受性良好。
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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 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.

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来源期刊
Dermatologic Surgery
Dermatologic Surgery 医学-皮肤病学
CiteScore
3.10
自引率
16.70%
发文量
547
期刊介绍: Exclusively devoted to dermatologic surgery, the Dermatologic Surgery journal publishes the most clinically comprehensive and up-to-date information in its field. This unique monthly journal provides today’s most expansive and in-depth coverage of cosmetic and reconstructive skin surgery and skin cancer through peer-reviewed original articles, extensive illustrations, case reports, ongoing features, literature reviews and correspondence. The journal provides information on the latest scientific information for all types of dermatologic surgery including: -Ambulatory phlebectomy- Blepharoplasty- Body contouring- Chemical peels- Cryosurgery- Curettage and desiccation- Dermabrasion- Excision and closure- Flap Surgery- Grafting- Hair restoration surgery- Injectable neuromodulators- Laser surgery- Liposuction- Microdermabrasion- Microlipoinjection- Micropigmentation- Mohs micrographic surgery- Nail surgery- Phlebology- Sclerotherapy- Skin cancer surgery- Skin resurfacing- Soft-tissue fillers. Dermatologists, dermatologic surgeons, plastic surgeons, oculoplastic surgeons and facial plastic surgeons consider this a must-read publication for anyone in the field.
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