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Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy
INTRODUCTION: Randomized controlled trials (RCTs) suggested that liquid formulation of botulinum toxin type A (aboBoNT-A) is safe and effective, but data confirming these characteristics in a real-life heterogenous set of patients are currently lacking. This study aimed to assess the efficacy and sa...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10307755/ https://www.ncbi.nlm.nih.gov/pubmed/37316750 http://dx.doi.org/10.1007/s13555-023-00951-x |
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author | Di Gregorio, Carlo Tretti-Clementoni, Matteo Belmontesi, Magda Romagnoli, Marina Innocenti, Alessandro Zanchi, Malvina Leone, Lucia Damiani, Giovanni Iozzo, Ivano |
author_facet | Di Gregorio, Carlo Tretti-Clementoni, Matteo Belmontesi, Magda Romagnoli, Marina Innocenti, Alessandro Zanchi, Malvina Leone, Lucia Damiani, Giovanni Iozzo, Ivano |
author_sort | Di Gregorio, Carlo |
collection | PubMed |
description | INTRODUCTION: Randomized controlled trials (RCTs) suggested that liquid formulation of botulinum toxin type A (aboBoNT-A) is safe and effective, but data confirming these characteristics in a real-life heterogenous set of patients are currently lacking. This study aimed to assess the efficacy and safety of the ready-to-use aboBoNT-A solution in adults with moderate-to-severe glabellar wrinkles. METHODS: In this real-life, multicenter, retrospective, observational study, healthy adults were treated at baseline only with aboBoNT-A solution on the glabellar area and followed up for 24 weeks. Re-treatment after 20–24 weeks could also be combined with other aesthetic procedures. Family history of immune-mediated inflammatory diseases (IMIDs) was not an exclusion criterion. Patient-reported outcomes (patient’s satisfaction and injection-related pain) and physician-reported outcomes (Physician Global Assessment, PGA) were collected. RESULTS: Of the 542 patients enrolled in the study, 38 had IMID family history. Injection-related pain was reported in 128 (23.62%) as mild (pain VAS = 1.34 ± 0.87) mainly by non-botulinum toxin treatment-naïve women under 50 years of age. At 48 h, physicians rated the clinical result as “improved” in 64% of patients, conversely 264 patients (48.71%) self-evaluated as “satisfied”/”very satisfied”. At 4 weeks a touch-up (< 10 units) was performed in 11 (2.03%) patients and 98.2% were “highly satisfied”. Re-treatment was performed in 330 (61.45%) patients, mainly botulinum-experienced, at 20 weeks and in 207 (38.55%), mainly botulinum naïve, at 24 weeks. A total of 403 (74.35%) patients were re-treated with the three-point technique and 201 (37.08%) also received hyaluronic acid filler in the lower central face and middle third. There were no cases of de novo IMIDs. CONCLUSIONS: Real-world data confirmed that aboBoNT-A is a fast, efficient, durable, reproducible, and easy-to-use drug which is also well tolerated in patients with family history of IMID. |
format | Online Article Text |
id | pubmed-10307755 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-103077552023-06-30 Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy Di Gregorio, Carlo Tretti-Clementoni, Matteo Belmontesi, Magda Romagnoli, Marina Innocenti, Alessandro Zanchi, Malvina Leone, Lucia Damiani, Giovanni Iozzo, Ivano Dermatol Ther (Heidelb) Brief Report INTRODUCTION: Randomized controlled trials (RCTs) suggested that liquid formulation of botulinum toxin type A (aboBoNT-A) is safe and effective, but data confirming these characteristics in a real-life heterogenous set of patients are currently lacking. This study aimed to assess the efficacy and safety of the ready-to-use aboBoNT-A solution in adults with moderate-to-severe glabellar wrinkles. METHODS: In this real-life, multicenter, retrospective, observational study, healthy adults were treated at baseline only with aboBoNT-A solution on the glabellar area and followed up for 24 weeks. Re-treatment after 20–24 weeks could also be combined with other aesthetic procedures. Family history of immune-mediated inflammatory diseases (IMIDs) was not an exclusion criterion. Patient-reported outcomes (patient’s satisfaction and injection-related pain) and physician-reported outcomes (Physician Global Assessment, PGA) were collected. RESULTS: Of the 542 patients enrolled in the study, 38 had IMID family history. Injection-related pain was reported in 128 (23.62%) as mild (pain VAS = 1.34 ± 0.87) mainly by non-botulinum toxin treatment-naïve women under 50 years of age. At 48 h, physicians rated the clinical result as “improved” in 64% of patients, conversely 264 patients (48.71%) self-evaluated as “satisfied”/”very satisfied”. At 4 weeks a touch-up (< 10 units) was performed in 11 (2.03%) patients and 98.2% were “highly satisfied”. Re-treatment was performed in 330 (61.45%) patients, mainly botulinum-experienced, at 20 weeks and in 207 (38.55%), mainly botulinum naïve, at 24 weeks. A total of 403 (74.35%) patients were re-treated with the three-point technique and 201 (37.08%) also received hyaluronic acid filler in the lower central face and middle third. There were no cases of de novo IMIDs. CONCLUSIONS: Real-world data confirmed that aboBoNT-A is a fast, efficient, durable, reproducible, and easy-to-use drug which is also well tolerated in patients with family history of IMID. Springer Healthcare 2023-06-14 /pmc/articles/PMC10307755/ /pubmed/37316750 http://dx.doi.org/10.1007/s13555-023-00951-x Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Brief Report Di Gregorio, Carlo Tretti-Clementoni, Matteo Belmontesi, Magda Romagnoli, Marina Innocenti, Alessandro Zanchi, Malvina Leone, Lucia Damiani, Giovanni Iozzo, Ivano Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy |
title | Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy |
title_full | Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy |
title_fullStr | Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy |
title_full_unstemmed | Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy |
title_short | Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy |
title_sort | real-world, retrospective, multicenter, observational study on the use of the first liquid abobotulinumtoxina in italy |
topic | Brief Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10307755/ https://www.ncbi.nlm.nih.gov/pubmed/37316750 http://dx.doi.org/10.1007/s13555-023-00951-x |
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