{"title":"Neauvia Intense 矫正中重度鼻唇沟的有效性和安全性:一项上市后、前瞻性、开放标签、单中心研究。","authors":"Nicola Zerbinati, Anna Płatkowska, Stefania Guida, Giorgio Stabile, Roberto Mocchi, Chiara Barlusconi, Sabrina Sommatis, Leonardo Garutti, Raffaele Rauso, Giovanna Cipolla, Luca Bettolini, Stefano Bighetti","doi":"10.2147/CCID.S460973","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong> 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.</p><p><strong>Patients and methods: </strong>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).</p><p><strong>Results: </strong> 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.</p><p><strong>Conclusion: </strong> 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.</p>","PeriodicalId":10447,"journal":{"name":"Clinical, Cosmetic and Investigational Dermatology","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11178092/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Neauvia Intense in Correcting Moderate-to-Severe Nasolabial Folds: A Post-Market, Prospective, Open-Label, Single-Centre Study.\",\"authors\":\"Nicola Zerbinati, Anna Płatkowska, Stefania Guida, Giorgio Stabile, Roberto Mocchi, Chiara Barlusconi, Sabrina Sommatis, Leonardo Garutti, Raffaele Rauso, Giovanna Cipolla, Luca Bettolini, Stefano Bighetti\",\"doi\":\"10.2147/CCID.S460973\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong> 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.</p><p><strong>Patients and methods: </strong>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).</p><p><strong>Results: </strong> 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.</p><p><strong>Conclusion: </strong> 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.</p>\",\"PeriodicalId\":10447,\"journal\":{\"name\":\"Clinical, Cosmetic and Investigational Dermatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-06-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11178092/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical, Cosmetic and Investigational Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/CCID.S460973\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical, Cosmetic and Investigational Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/CCID.S460973","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Efficacy and Safety of Neauvia Intense in Correcting Moderate-to-Severe Nasolabial Folds: A Post-Market, Prospective, Open-Label, Single-Centre Study.
Purpose: 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.
Patients and methods: 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).
Results: 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.
Conclusion: 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.
期刊介绍:
Clinical, Cosmetic and Investigational Dermatology is an international, peer-reviewed, open access journal that focuses on the latest clinical and experimental research in all aspects of skin disease and cosmetic interventions. Normal and pathological processes in skin development and aging, their modification and treatment, as well as basic research into histology of dermal and dermal structures that provide clinical insights and potential treatment options are key topics for the journal.
Patient satisfaction, preference, quality of life, compliance, persistence and their role in developing new management options to optimize outcomes for target conditions constitute major areas of interest.
The journal is characterized by the rapid reporting of clinical studies, reviews and original research in skin research and skin care.
All areas of dermatology will be covered; contributions will be welcomed from all clinicians and basic science researchers globally.