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冷交联氨酸填充剂的长期安全性和有效性:多中心,随机,受控,双盲研究

Michael S Kaminer¹, Rui L Avelar², Leslie Baumann³

¹Dermatologist in private practice in Chestnut Hill, MA, USA.

Aesthetic surgery journal

|May 16, 2025

概括

通过冷交叉连接创建的新型酸填充剂EVOLYSSE FORM (EVLF) 和EVOLYSSE SMOOTH (EVLS) 已经证明了安全性和有效性. 与传统方法相比,这些填充剂在动态面部纹和纹方面提供了优异的结果.

科学领域:

皮肤病学皮肤病学
审美医学是一种美学医学.
生物材料科学生物材料科学

背景情况:

推出了EVOLYSSE FORM (EVLF) 和EVOLYSSE SMOOTH (EVLS),这两种新型的氨酸填充剂采用了创新的冷交叉连接工艺.
这些填充剂代表了用于美观应用的皮肤填充技术的进步.

研究的目的:

评估新的冷交联氨酸填充剂的安全性和有效性.
收集支持美国监管机构批准纠正中度至严重的动态面部纹和纹的数据.
为了比较冷交叉连接填充剂与传统交叉连接填充剂的性能.

主要方法:

一项随机,受控,分面研究,涉及140名中度至重度鼻皮的受试者.
一个鼻唇接收了一个冷交联填充剂 (EVLF或EVLS),而对侧接收Restylane-L (RESL).
随访延长至12个月,包括可选的再处理和随后的安全监测.

主要成果:

冷交联填充剂在6个月后在减少纹严重性方面表现出非劣势性和统计上的优势.
在12个月内,EVLF比RESL显著改善;EVLS在6个月和9个月显著改善.
在使用全球美学改进量表的所有评估组 (评估者,调查人员,受试者) 中观察到高响应率.
在所有治疗组中,在FACE-Q评估中发现了鼻皮的显著改善.

结论:

新型冷交联酸填充剂 (EVLF和EVLS) 是安全有效的,用于修复鼻唇.
结果表明持续有效性长达一年.
冷交联过程为皮肤填充剂开发提供了一个有希望的替代方案.

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