Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19
MBA-P01 is a newly developed botulinum toxin A (BoNT-A) product designed to provide similar clinical effects as OnabotulinumtoxinA (ONA-BoNT-A), thereby providing an alternative treatment option for glabellar lines. It is another holotoxin preparation containing BoNT-A1. This randomized, double-blin...
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2025-03-01
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| author | Hye Sung Han Won-Serk Kim Yangwon Lee Chong-Hyun Won Wooshun Lee Sun Young Choi Beom Joon Kim |
| author_facet | Hye Sung Han Won-Serk Kim Yangwon Lee Chong-Hyun Won Wooshun Lee Sun Young Choi Beom Joon Kim |
| author_sort | Hye Sung Han |
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| description | MBA-P01 is a newly developed botulinum toxin A (BoNT-A) product designed to provide similar clinical effects as OnabotulinumtoxinA (ONA-BoNT-A), thereby providing an alternative treatment option for glabellar lines. It is another holotoxin preparation containing BoNT-A1. This randomized, double-blind, active-controlled, multi-center, Phase III clinical trial aimed to evaluate the efficacy and safety of MBA-P01 compared with OnabotulinumtoxinA (ONA-BoNT-A). In total, 318 participants were enrolled and received 20 units of MBA-P01 or ONA-BoNT-A on the forehead and glabella. At the 4-week assessment, the primary endpoint revealed no significant difference in the improvement rate of glabellar wrinkles between the two groups, confirming the non-inferiority of MBA-P01 to ONA-BoNT-A. Furthermore, some evaluation variables showed higher improvement rates for MBA-P01 than for ONA-BoNT-A. Adverse reactions and other safety analysis results were considered acceptable. Interestingly, a subgroup analysis of patients with the coronavirus disease (COVID-19) showed that the duration of BoNT-A treatment was shorter among those who contracted COVID-19 after BoNT-A treatment compared with those who have not. The limitations of this study include the predominance of female participants and the exclusive enrollment of Korean patients. MBA-P01 is expected to be clinically useful in terms of the efficient and safe reduction of glabellar wrinkles, which will provide patients with additional treatment options. |
| format | Article |
| id | doaj-art-e0c7280310b246ca8c5c84aa0faa856e |
| institution | OA Journals |
| issn | 2072-6651 |
| language | English |
| publishDate | 2025-03-01 |
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| series | Toxins |
| spelling | doaj-art-e0c7280310b246ca8c5c84aa0faa856e2025-08-20T02:25:03ZengMDPI AGToxins2072-66512025-03-0117416010.3390/toxins17040160Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19Hye Sung Han0Won-Serk Kim1Yangwon Lee2Chong-Hyun Won3Wooshun Lee4Sun Young Choi5Beom Joon Kim6Department of Dermatology, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si 14353, Republic of KoreaDepartment of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, Republic of KoreaDepartment of Dermatology, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of KoreaMedytox Inc., Seoul 06175, Republic of KoreaDepartment of Dermatology, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si 14353, Republic of KoreaDepartment of Dermatology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul 06974, Republic of KoreaMBA-P01 is a newly developed botulinum toxin A (BoNT-A) product designed to provide similar clinical effects as OnabotulinumtoxinA (ONA-BoNT-A), thereby providing an alternative treatment option for glabellar lines. It is another holotoxin preparation containing BoNT-A1. This randomized, double-blind, active-controlled, multi-center, Phase III clinical trial aimed to evaluate the efficacy and safety of MBA-P01 compared with OnabotulinumtoxinA (ONA-BoNT-A). In total, 318 participants were enrolled and received 20 units of MBA-P01 or ONA-BoNT-A on the forehead and glabella. At the 4-week assessment, the primary endpoint revealed no significant difference in the improvement rate of glabellar wrinkles between the two groups, confirming the non-inferiority of MBA-P01 to ONA-BoNT-A. Furthermore, some evaluation variables showed higher improvement rates for MBA-P01 than for ONA-BoNT-A. Adverse reactions and other safety analysis results were considered acceptable. Interestingly, a subgroup analysis of patients with the coronavirus disease (COVID-19) showed that the duration of BoNT-A treatment was shorter among those who contracted COVID-19 after BoNT-A treatment compared with those who have not. The limitations of this study include the predominance of female participants and the exclusive enrollment of Korean patients. MBA-P01 is expected to be clinically useful in terms of the efficient and safe reduction of glabellar wrinkles, which will provide patients with additional treatment options.https://www.mdpi.com/2072-6651/17/4/160glabellar linesbotulinum toxin AMBA-P01coronavirus disease |
| spellingShingle | Hye Sung Han Won-Serk Kim Yangwon Lee Chong-Hyun Won Wooshun Lee Sun Young Choi Beom Joon Kim Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19 Toxins glabellar lines botulinum toxin A MBA-P01 coronavirus disease |
| title | Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19 |
| title_full | Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19 |
| title_fullStr | Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19 |
| title_full_unstemmed | Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19 |
| title_short | Efficacy and Safety of a Newly Developed Botulinum Toxin A (MBA-P01) in Patients with Moderate-to-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center, Phase III Study with a Subgroup Analysis on Patients with COVID-19 |
| title_sort | efficacy and safety of a newly developed botulinum toxin a mba p01 in patients with moderate to severe glabellar lines a randomized double blind active controlled multi center phase iii study with a subgroup analysis on patients with covid 19 |
| topic | glabellar lines botulinum toxin A MBA-P01 coronavirus disease |
| url | https://www.mdpi.com/2072-6651/17/4/160 |
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