Evidence map›Paper›PMID 40278658›Full record

Trial reportToxins2025

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.

Hye Sung Han, Won-Serk Kim, Yangwon Lee, Chong-Hyun Won, Wooshun Lee, Sun Young Choi, Beom Joon Kim

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Toxins, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Hye Sung HanDepartment of Dermatology, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si 14353, Republic of Korea.ORCID 0000-0002-3556-0740
Won-Serk KimDepartment of Dermatology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, Republic of Korea.
Yangwon LeeDepartment of Dermatology, Konkuk University School of Medicine, Seoul 05030, Republic of Korea.
Chong-Hyun WonDepartment of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.ORCID 0000-0003-1997-2240
Wooshun LeeMedytox Inc., Seoul 06175, Republic of Korea.ORCID 0000-0003-0385-1495
Sun Young ChoiDepartment of Dermatology, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong-si 14353, Republic of Korea.ORCID 0000-0003-0248-7708
Beom Joon KimDepartment of Dermatology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul 06974, Republic of Korea.

Funding

NUMECO Inc. none
6 · The paper itself

Abstract

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.

Indexed as

Botulinum Toxins, Type ACOVID-19Neuromuscular AgentsSkin AgingAdultAgedDouble-Blind MethodFemaleForeheadHumansMaleMiddle AgedSARS-CoV-2Treatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsbotulinum toxin Acoronavirus diseaseglabellar linesMBA-P01

Identifiers

PMID40278658
PMCPMC12031167

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.