Evidence map›Paper›PMID 40548382›Full record

ReviewJournal of cosmetic dermatology2025

Revealing the Patient Perspective: Evolution of Patient-Reported Outcome Measures in Botulinum Toxin Studies in Aesthetic Medicine.

Steven Dayan, Alexander Z Rivkin, Patricia Ogilvie, Jean D A Carruthers, Yan Wu, Elisabeth Lee, Vaishali Patel, Maria Musumeci

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of cosmetic dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Review
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

8 authors.

Steven DayanDivision of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, University of Illinois at Chicago, Chicago, Illinois, USA.
Alexander Z RivkinDavid Geffen/UCLA School of Medicine, University of California at Los Angeles, Los Angeles, California, USA.
Patricia OgilviePrivate Practice, Skin Concept, Munich, Germany.
Jean D A CarruthersDepartment of Ophthalmology, University of British Columbia, Vancouver, British Columbia, Canada.
Yan WuPeking University First Hospital, Beijing, China.
Elisabeth LeeClinical Development Head for Toxins, Allergan Aesthetics, an AbbVie Company, Irvine, California, USA.
Vaishali PatelPatient Centered Outcomes Research, Allergan Aesthetics, an AbbVie Company, Irvine, California, USA.
Maria MusumeciGlobal Lead Neurotoxin, Global Aesthetics Medical Affairs, Allergan Aesthetics, an AbbVie Company, Rome, Italy.

Funding

Allergan Aesthetics, an AbbVie company
6 · The paper itself

Abstract

backgroundOnabotulinumtoxinA has been licensed for the treatment of upper facial lines for over 20 years. Patient benefits extend well beyond correction of the lines themselves-including positive effects on confidence, self-esteem, feelings of attractiveness, and age appearance. Regulatory bodies recommend that patient-reported outcomes (PROs) are routinely included in registrational studies to ensure the patient perspective is considered. Essential guidance is available from regulators and other expert groups to aid the development, validation, and use of appropriate PROs.

aimsTo reflect on the evolution of patient experience data collection in onabotulinumtoxinA aesthetic medicine development programs within the context of PRO usage across approved botulinum toxins.

methodsLiterature searches were performed to identify relevant publications.

resultsSeveral PRO instruments have been rigorously developed and validated following regulatory guidance and implemented in onabotulinumtoxinA clinical programs. These include the Facial Line Outcomes Questionnaire (FLO-11) and Facial Line Satisfaction Questionnaire (FLSQ). The data generated have supported the licensing process and enabled a deeper understanding of patient perspectives. Although these instruments were developed for clinical studies, the concepts obtained directly from patient interviews align with patient goals in clinical practice. Similarly, PROs such as FACE-Q are now employed more widely across approved botulinum toxins.

conclusionsA patient-centric approach, in lockstep with regulatory requirements, has been central to onabotulinumtoxinA development. Awareness of the comprehensive benefits of aesthetic treatments should continue to improve based on increasingly robust PROs.

Indexed as

Botulinum Toxins, Type ACosmetic TechniquesNeuromuscular AgentsPatient Reported Outcome MeasuresSkin AgingEstheticsHumansPatient SatisfactionSurveys and QuestionnairesBotulinum Toxins, Type ANeuromuscular Agentsonabotulinum toxin Abotulinum neurotoxin type Aforehead linesglabellar lineslateral canthal linesonabotulinumtoxinApatient‐focused drug developmentpatient‐reported outcomes

Identifiers

PMID40548382
PMCPMC12183674

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.