{"title":"左肉毒杆菌毒素、单肉毒杆菌毒素和肉毒杆菌毒素的扩散特性及其对肌肉松弛的影响：一项随机裂面临床试验。","authors":"Maxine Bennek, Daniela Rudowitz, Martina Kerscher","doi":"10.1007/s13555-025-01458-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Injections with botulinumtoxinA (BoNTA) are the most common nonsurgical aesthetic procedure but carry risks such as unintended muscle diffusion. Understanding formulation behavior is key to optimizing safety and efficacy. This study compares the diffusion characteristics from letibotulinumtoxinA (Leti-BoNTA) to onabotulinumtoxinA (Ona-BoNTA) and abobotulinumtoxinA (Abo-BoNTA) and its impact on muscle relaxation of frontalis muscle.</p><p><strong>Methods: </strong>In a double-blind, randomized trial, 30 healthy adults received Leti-BoNTA on one forehead side and either Ona-BoNTA or Abo-BoNTA on the other. Anhidrosis was measured via Minor's starch test over 6 months, and wrinkle severity was assessed using standardized photography and the Croma Scale.</p><p><strong>Results: </strong>Leti-BoNTA had a significantly smaller maximal anhidrotic area than Ona-BoNTA (-15.1 ± 5.5 cm<sup>2</sup>, p < 0.001) and Abo-BoNTA (-25.2 ± 14.5 cm<sup>2</sup>, p < 0.001). An area under the curve (AUC) analysis confirmed the largest area of anhidrosis for Abo-BONTA over the 6-month period, followed by Ona-BONTA and Leti-BoNTA. Despite its lower diffusion, Leti-BoNTA effectively improved wrinkles, with ≥ 1-point improvement in 92% of subjects by week 2.</p><p><strong>Conclusions: </strong>Leti-BoNTA provides wrinkle reduction with a more limited diffusion, as assessed with the Minor's starch-iodine test. Its precise action in this trial implies to be a viable option when controlled spread is essential.</p><p><strong>Clinical trial registration: </strong>The trial EU CT: 2024-511047-26-01 was registered on 23 March 2024.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2147-2158"},"PeriodicalIF":3.5000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256374/pdf/","citationCount":"0","resultStr":"{\"title\":\"Diffusion Characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA, and AbobotulinumtoxinA and its Impact on Muscle Relaxation: A Randomized Split-Face Clinical Trial.\",\"authors\":\"Maxine Bennek, Daniela Rudowitz, Martina Kerscher\",\"doi\":\"10.1007/s13555-025-01458-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Injections with botulinumtoxinA (BoNTA) are the most common nonsurgical aesthetic procedure but carry risks such as unintended muscle diffusion. Understanding formulation behavior is key to optimizing safety and efficacy. This study compares the diffusion characteristics from letibotulinumtoxinA (Leti-BoNTA) to onabotulinumtoxinA (Ona-BoNTA) and abobotulinumtoxinA (Abo-BoNTA) and its impact on muscle relaxation of frontalis muscle.</p><p><strong>Methods: </strong>In a double-blind, randomized trial, 30 healthy adults received Leti-BoNTA on one forehead side and either Ona-BoNTA or Abo-BoNTA on the other. Anhidrosis was measured via Minor's starch test over 6 months, and wrinkle severity was assessed using standardized photography and the Croma Scale.</p><p><strong>Results: </strong>Leti-BoNTA had a significantly smaller maximal anhidrotic area than Ona-BoNTA (-15.1 ± 5.5 cm<sup>2</sup>, p < 0.001) and Abo-BoNTA (-25.2 ± 14.5 cm<sup>2</sup>, p < 0.001). An area under the curve (AUC) analysis confirmed the largest area of anhidrosis for Abo-BONTA over the 6-month period, followed by Ona-BONTA and Leti-BoNTA. Despite its lower diffusion, Leti-BoNTA effectively improved wrinkles, with ≥ 1-point improvement in 92% of subjects by week 2.</p><p><strong>Conclusions: </strong>Leti-BoNTA provides wrinkle reduction with a more limited diffusion, as assessed with the Minor's starch-iodine test. Its precise action in this trial implies to be a viable option when controlled spread is essential.</p><p><strong>Clinical trial registration: </strong>The trial EU CT: 2024-511047-26-01 was registered on 23 March 2024.</p>\",\"PeriodicalId\":11186,\"journal\":{\"name\":\"Dermatology and Therapy\",\"volume\":\" \",\"pages\":\"2147-2158\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256374/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13555-025-01458-3\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/6/17 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01458-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/6/17 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
简介：注射肉毒杆菌毒素（BoNTA）是最常见的非手术美容手术，但有风险，如意外的肌肉扩散。了解制剂行为是优化安全性和有效性的关键。本研究比较左肉毒杆菌毒素（Leti-BoNTA）对单肉毒杆菌毒素（Ona-BoNTA）和肉毒杆菌毒素（Abo-BoNTA）的扩散特性及其对额肌肌肉松弛的影响。方法：在一项双盲随机试验中，30名健康成人在一侧前额接受Leti-BoNTA治疗，另一侧前额接受Ona-BoNTA或Abo-BoNTA治疗。在6个月内通过Minor's淀粉试验测量无汗症，并使用标准化摄影和Croma量表评估皱纹严重程度。结果：Leti-BoNTA的最大无汗面积明显小于Ona-BoNTA（-15.1±5.5 cm2, p 2, p）结论：通过Minor的淀粉-碘试验评估，Leti-BoNTA可以减少皱纹，但扩散更有限。在本试验中，它的精确作用表明，在控制扩散至关重要的情况下，它是一种可行的选择。临床试验注册：该试验EU CT: 2024-511047-26-01于2024年3月23日注册。
Diffusion Characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA, and AbobotulinumtoxinA and its Impact on Muscle Relaxation: A Randomized Split-Face Clinical Trial.
Introduction: Injections with botulinumtoxinA (BoNTA) are the most common nonsurgical aesthetic procedure but carry risks such as unintended muscle diffusion. Understanding formulation behavior is key to optimizing safety and efficacy. This study compares the diffusion characteristics from letibotulinumtoxinA (Leti-BoNTA) to onabotulinumtoxinA (Ona-BoNTA) and abobotulinumtoxinA (Abo-BoNTA) and its impact on muscle relaxation of frontalis muscle.
Methods: In a double-blind, randomized trial, 30 healthy adults received Leti-BoNTA on one forehead side and either Ona-BoNTA or Abo-BoNTA on the other. Anhidrosis was measured via Minor's starch test over 6 months, and wrinkle severity was assessed using standardized photography and the Croma Scale.
Results: Leti-BoNTA had a significantly smaller maximal anhidrotic area than Ona-BoNTA (-15.1 ± 5.5 cm2, p < 0.001) and Abo-BoNTA (-25.2 ± 14.5 cm2, p < 0.001). An area under the curve (AUC) analysis confirmed the largest area of anhidrosis for Abo-BONTA over the 6-month period, followed by Ona-BONTA and Leti-BoNTA. Despite its lower diffusion, Leti-BoNTA effectively improved wrinkles, with ≥ 1-point improvement in 92% of subjects by week 2.
Conclusions: Leti-BoNTA provides wrinkle reduction with a more limited diffusion, as assessed with the Minor's starch-iodine test. Its precise action in this trial implies to be a viable option when controlled spread is essential.
Clinical trial registration: The trial EU CT: 2024-511047-26-01 was registered on 23 March 2024.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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