Evidence map›Paper›PMID 35922149›Full record

Trial reportAesthetic surgery journal2022

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

Nowell Solish, Benjamin Ascher, Rui L Avelar, Vince Bertucci, Isaac Bodokh, Jean Carruthers, Hugues Cartier, Henry Delmar, Ralf Denfeld, Marc Heckmann and 9 more

Open access · hybridAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Aesthetic surgery journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
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

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
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  4. Review
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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

19 authors at 12 institutions in 5 countries.

Nowell SolishUniversity of Toronto, Toronto, ON, Canada.
Benjamin AscherParis Academy, Paris, France.
Rui L AvelarEvolus, Inc., Newport Beach, CA, USA.
Vince BertucciDivision of Dermatology, University of Toronto, Toronto, ON, Canada.
Isaac BodokhPracticien Hospitalier, Service de Dermatologie, Cannes Hospital Simone Veil, Cannes, France.
Jean CarruthersDepartment of Ophthalmology, University of British Columbia, Vancouver, BC, Canada.
Hugues CartierCentre Médical Saint-Jean, Arras, France.
Henry Delmarprivate practice in Cap d'Antibes, France.
Ralf Denfeldprivate practice in Stuttgart, Germany.
Marc HeckmannLudwig Maximilian Universität, Munich, Germany.
Per HedénKarolinska Institute, Art Clinic, Stockholm, Sweden.
Said Hiltonprivate practice in Düsseldorf, Germany.
Christopher Inglefieldprivate practice in London, UK.
Patricia Ogilvieprivate practice in Munich, Germany.
Berthold-Josef Rzanyprivate practice in Vienna, Austria.
Gerhard SattlerRosenpark Research, Darmstadt, Germany.
Michael Sebastianprivate practice in Mahlow, Germany.
Arthur SwiftMcGill University, Montreal, PQ, Canada.
Patrick Trévidicprivate practice in Paris, France.
University of Toronto · CACentre Hospitalier d'Arras · FRCentre Hospitalier de Cannes · FRCentre Procédés, Energies Renouvelables et Systèmes Energétiques · FRJanus University · USKarolinska Institutet · SELudwig-Maximilians-Universität München · DEMahlo (Germany) · DEMcGill University · CARosenpark Klinik · DEStuttgart Technical University of Applied Sciences · DEUniversity of British Columbia · CA

Funding

Evolus, Inc
6 · The paper itself

Abstract

backgroundDespite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited.

objectivesThe authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines.

methodsPost-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale.

resultsCompared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (P > 0.05 at all visits) by an absolute overall mean difference of 10.1% across all visits. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis.

conclusionsThe percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across all measures, differences between the 2 treatment groups did not reach statistical significance. Further study is warranted to establish if these post-hoc analyses observations are reproducible in a larger male patient population. LEVEL OF EVIDENCE: 1:

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsAdultDouble-Blind MethodHumansMaleTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsprabotulinumtoxin A

Identifiers

PMID35922149
PMCPMC9750667
OpenAlexW4289704697

What OpenQuestion holds

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Registered trials

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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.