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前瞻性临床试验证明透明质酸填充剂改善萎缩性面部瘢痕长达 2 年的疗效。

Prospective Clinical Trial Demonstrating the Efficacy of Hyaluronic Acid Filler for the Improvement of Atrophic Facial Scars up to 2 years.

机构信息

Florida Atlantic University, Boca Raton, Florida.

Siperstein Dermatology Group, Boynton Beach, Florida.

出版信息

Dermatol Surg. 2024 Dec 1;50(12):1143-1148. doi: 10.1097/DSS.0000000000004315. Epub 2024 Jul 5.

Abstract

BACKGROUND

Hyaluronic acid (HA) filler longevity has been studied for wrinkles. However, its long-term use for treating atrophic facial scars has not yet been analyzed in long-term prospective studies.

OBJECTIVE

Analyze the safety and duration of a HA filler for the use in atrophic scars.

MATERIALS AND METHODS

Fifteen subjects received VYC-17.5L in atrophic scars on 1 randomized cheek and saline on the other, with 1 optional touch-up treatment and crossover after the short-term trial. Grading for this long-term extension was done on Day 720, using the Global Aesthetic Improvement Scale (GAIS) and the Quantitative Global Scarring Grading System.

RESULTS

On Day 720, a live blind evaluator rated the VYC-17.5L assigned side as having significant reduction in scar severity (-7.2 [t(22) = -6.01, p = .00009]) and number of scars (-8.8 [t(22) = -6.25, p = .00006]) as compared with baseline. There was no significant difference in the results from Day 120 to Day 720. Ninety-two percent (11/12) of subjects reported improvement (GAIS), were satisfied with the treatment, thought it looked natural, and had fewer side effects than expected. There were no persistent or late-onset side effects.

CONCLUSION

VYC-17.5L improved rolling atrophic facial scars, and the results were sustained throughout the 2-year trial without side effects.

摘要

背景

已有研究分析了透明质酸(HA)填充剂在皱纹方面的长效性,但尚未对其长期用于治疗萎缩性面部瘢痕进行长期前瞻性研究。

目的

分析 HA 填充剂治疗萎缩性瘢痕的安全性和持久性。

材料和方法

15 名受试者随机在一侧面颊接受 VYC-17.5L 治疗,另一侧接受生理盐水治疗,在短期试验后进行了 1 次可选的追加治疗和交叉。在第 720 天,使用全球美学改善量表(GAIS)和定量整体瘢痕分级系统对长期扩展进行分级。

结果

在第 720 天,一位盲法活体评估员对 VYC-17.5L 治疗侧的瘢痕严重程度评分(-7.2 [t(22) = -6.01,p =.00009])和瘢痕数量评分(-8.8 [t(22) = -6.25,p =.00006])与基线相比有显著降低。从第 120 天到第 720 天,结果没有显著差异。92%(11/12)的受试者报告改善(GAIS),对治疗满意,认为效果自然,且副作用比预期少。没有持续或迟发性副作用。

结论

VYC-17.5L 改善了滚动性萎缩性面部瘢痕,并且在 2 年的试验中没有副作用,结果持续存在。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8572/11594006/884157c11d1d/ds-50-1143-g001.jpg

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