Kaminer Michael S, Avelar Rui L, Baumann Leslie, Callender Valerie, Dayan Steven H, Green Jeremy B, Grekin Steven K, Guyon Sebastien
Aesthet Surg J. 2025 Jul 15;45(8):842-849. doi: 10.1093/asj/sjaf080.
Evolysse Form (EVLF) and Evolysse Smooth (EVLS) (Symatese, Chaponost, France) are new hyaluronic acid fillers created using an innovative cold-crosslinking process.
The authors of this study aim to collect safety and effectiveness data on new cold-crosslinked fillers to support the US approval for the correction of moderate-to-severe dynamic facial wrinkles and folds.
In this randomized, controlled, split-face study, 140 patients with moderate-to-severe nasolabial folds (NLFs) received a cold-crosslinked filler in 1 NLF (EVLF = 70, EVLS = 70) and a traditionally crosslinked filler, Restylane-L (RESL), in the contralateral fold and were followed through 12 months with an optional retreatment at that time point and subsequent 3 months of safety follow-up.
The primary endpoint of mean Wrinkle Severity Rating Scale change from baseline to Month 6 as rated by the photographic review panel demonstrated noninferiority and statistical superiority for the cold-crosslinked fillers. Blinded evaluator Wrinkle Severity Rating Scale assessments showed a mean change from baseline that was statistically significantly better than RESL for EVLF at all visits through 12 months and for EVLS at 6 and 9 months. Most patients were responders on the Global Aesthetic Improvement Scale throughout the study, according to ratings by blinded evaluators, treating investigators, and patients. The FACE-Q appraisal of NLFs' overall mean score showed significant improvement from baseline (P < .0001) at all time points through Month 12 for all treatment groups. All treatments were well tolerated.
The new cold-crosslinked fillers were shown to be safe and effective for correction of NLFs, with results lasting for 1 year.
Evolysse Form（EVLF）和Evolysse Smooth（EVLS）（法国沙波诺斯特的Symatese公司）是采用创新的冷交联工艺制成的新型透明质酸填充剂。
本研究的作者旨在收集新型冷交联填充剂的安全性和有效性数据，以支持其在美国获批用于矫正中重度动态面部皱纹和褶皱。
在这项随机、对照、半脸研究中，140例中重度鼻唇沟（NLF）患者在一侧鼻唇沟注射一种冷交联填充剂（EVLF = 70例，EVLS = 70例），在对侧鼻唇沟注射传统交联填充剂瑞蓝 - L（RESL），并随访12个月，在该时间点可选择再次治疗，随后进行3个月的安全性随访。
由照片评审小组评定的从基线到第6个月的平均皱纹严重程度评分量表变化这一主要终点显示，冷交联填充剂具有非劣效性且在统计学上更具优势。盲法评估者的皱纹严重程度评分量表评估显示，在12个月的所有随访中，EVLF的基线平均变化在统计学上显著优于RESL，在6个月和9个月时，EVLS的基线平均变化也显著优于RESL。根据盲法评估者、治疗研究者和患者的评分，在整个研究过程中，大多数患者在全球美学改善量表上属于有反应者。所有治疗组在第12个月的所有时间点，NLFs的FACE - Q总体平均评分从基线均有显著改善（P <.0001）。所有治疗的耐受性良好。
新型冷交联填充剂被证明对矫正鼻唇沟安全有效，效果可持续1年。
