Diffusion Characteristics of LetibotulinumtoxinA, OnabotulinumtoxinA, and AbobotulinumtoxinA and its Impact on Muscle Relaxation: A Randomized Split-Face Clinical Trial.
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引用次数: 0
Abstract
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.