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Review
. 2025 Jul;24(7):e70311.
doi: 10.1111/jocd.70311.

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

Steven Dayan  1   2 , Alexander Z Rivkin  3 , Patricia Ogilvie  4 , Jean D A Carruthers  5 , Yan Wu  6 , Elisabeth Lee  7 , Vaishali Patel  8 , Maria Musumeci  9
Affiliations
Review

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

Steven Dayan et al. J Cosmet Dermatol. 2025 Jul.

Abstract

Background: OnabotulinumtoxinA 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.

Aims: To 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.

Methods: Literature searches were performed to identify relevant publications.

Results: Several 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.

Conclusions: A 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.

Keywords: botulinum neurotoxin type A; forehead lines; glabellar lines; lateral canthal lines; onabotulinumtoxinA; patient‐focused drug development; patient‐reported outcomes.

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Conflict of interest statement

Steven Dayan is a clinical investigator and consultant for AbbVie, Galderma, Merz, and Revance. Alexander Rivkin is an investigator, speaker, and consultant for AbbVie, Galderma, Merz, and Suneva. Patricia Ogilvie is an investigator for AbbVie, Galderma, Merz, Meditox, and Evolus, and a consultant for Revance. Jean Carruthers is a consultant and investigator for Acorn, Alastin, Appiell, AbbVie, Avari, Bonti, Del Nova, Evolus, Fount Bio, In Mode, Inverse Genomic, Jeune Aesthetics, Merz, Object Pharma, Revance, and Sofwave. Yan Wu is an investigator for AbbVie. Elisabeth Lee, Vaishali Patel, and Maria Musumeci are employees of Allergan Aesthetics, an AbbVie company.

Figures

FIGURE 1
FIGURE 1
Timeline of key developments: PROs and onabotulinumtoxinA in facial aesthetic indications. aThe clinical program underlying these approvals incorporated patients treated in all three upper facial areas (GL, LCL and FHL). CDE, Center for Drug Evaluation; EMA, European Medicines Agency; FDA, Food and Drug Administration; FHL, forehead lines; FLO‐11, Facial Line Outcomes Questionnaire; FLSQ, Facial Line Satisfaction Questionnaire; GL, glabellar lines; HRQoL, health‐related quality of life; ISPOR, Professional Society for Health Economics and Outcomes Research; LCL, lateral canthal lines; PFDD, patient‐focused drug development; PRO, patient‐reported outcome; UFL, upper facial lines.
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