■这个前景,单中心研究旨在评估NEAUVIAIntense的安全性和有效性,PEG交联聚合物水凝胶,在常规临床环境中纠正中度至重度鼻唇沟(NLF)。这项研究调查了美学结果,患者满意度,以及与注射填充剂相关的不良事件。
■最初招募了70名患者,有60个会议研究参数。上市后研究涉及单次治疗,在NLF的每一侧雇用NEAUVIAIntense。评估采用改良的菲茨帕特里克皱纹量表(MFWS),全球美学改进量表(GAIS),和视觉类比量表(VAS)。
■该研究表明,注射后立即组织抑制有统计学上的显着改善(p<0.001),持续效果长达6个月。MFWS评估显示,响应者患者在治疗后立即为96.6%,76.6%一个月,3个月后48.3%,6个月时为28.3%(p<0.001)。此外,治疗后MFWS评分的频率分布有显著变化(p<0.001),大多数患者在组织抑制方面有所改善。基于GAIS评估,在治疗后30天和90天观察到最大改善。患者和医生满意度,用VAS测量,随着时间的推移保持稳定,在治疗后4周和24周出现波动(p<0.001,Anova;p<0.05,Wilcoxon)。在纳入研究的患者的整个随访期间,未观察到与使用该产品相关的不良反应.
■NEAUVIAIntense被证明是纠正NLF的有效解决方案,在组织抑制和美学结果方面提供显著和持久的改善。该研究强调了在美容医学中进行持续评估的必要性,以使结果与不断变化的患者期望保持一致并优化长期结果。这些发现有助于理解这种特定的水凝胶填料,并突出了可注射填料在全面面部美学策略中的更广泛背景。
UNASSIGNED: This prospective, single-center study aims to evaluate the safety and effectiveness of NEAUVIA Intense, a PEG cross-linked polymeric hydrogel, in correcting moderate-to-severe nasolabial folds (NLF) in a routine clinical setting. The study investigates the aesthetic outcomes, patient satisfaction, and adverse events associated with the injectable filler.
UNASSIGNED: Seventy patients were initially enrolled, with 60 meeting study parameters. The post-market study involved a single session treatment, employing NEAUVIA Intense on each side of the NLF. Assessments utilized the Modified Fitzpatrick Wrinkle Scale (MFWS), Global Aesthetic Improvement Scale (GAIS), and Visual Analogical Scale (VAS).
UNASSIGNED: The study demonstrated a statistically significant improvement in tissue depression immediately post-injection (p < 0.001), with sustained effects up to 6 months. MFWS assessments revealed that responder patients were 96.6% immediately after treatment, 76.6% one month, 48.3% after 3 months, and 28.3% at 6 months (p < 0.001). Additionally, there was a significant change in the frequency distribution of MFWS scores post-treatment (p < 0.001), with the majority of patients experiencing improvement in tissue depression. Maximum improvement was observed at 30- and 90-days post-treatment based on GAIS assessments. Patient and physician satisfaction, measured by VAS, remained stable over time, with fluctuations at 4 and 24 weeks after treatment (p < 0.001, Anova; p < 0.05, Wilcoxon). Throughout the entire follow-up duration of the patients enrolled in the study, no adverse effects related to the use of the product were observed.
UNASSIGNED: NEAUVIA Intense proved to be an effective solution for correcting NLF, providing significant and lasting improvements in tissue depression and aesthetic outcomes. The study underscores the necessity for continuous assessment in aesthetic medicine to align outcomes with evolving patient expectations and optimize long-term results. The findings contribute to the understanding of this specific hydrogel filler and highlight the broader context of injectable fillers in comprehensive facial aesthetic strategies.