Dayan Steven, Rivkin Alexander Z, Ogilvie Patricia, Carruthers Jean D A, Wu Yan, Lee Elisabeth, Patel Vaishali, Musumeci Maria
Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, University of Illinois at Chicago, Chicago, Illinois, USA.
DeNova Research, Chicago, Illinois, USA.
J Cosmet Dermatol. 2025 Jul;24(7):e70311. doi: 10.1111/jocd.70311.
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.
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.
Literature searches were performed to identify relevant publications.
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.
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.
A型肉毒毒素已获许可用于治疗面部上半部分皱纹超过20年。患者的获益远不止于皱纹本身的改善，还包括对自信心、自尊、吸引力感受和年龄外观的积极影响。监管机构建议在注册研究中常规纳入患者报告结局（PROs），以确保考虑患者的观点。监管机构和其他专家组提供了基本指南，以协助开发、验证和使用适当的PROs。
在已批准的肉毒毒素使用PROs的背景下，反思A型肉毒毒素美容医学开发项目中患者体验数据收集的演变。
进行文献检索以识别相关出版物。
遵循监管指南严格开发并验证了几种PRO工具，并在A型肉毒毒素临床项目中实施。这些工具包括面部皱纹结局问卷（FLO - 11）和面部皱纹满意度问卷（FLSQ）。所产生的数据支持了许可过程，并使人们能够更深入地了解患者的观点。尽管这些工具是为临床研究开发的，但直接从患者访谈中获得的概念与临床实践中的患者目标一致。同样，诸如FACE - Q之类的PROs现在在已批准的肉毒毒素中得到了更广泛的应用。
以患者为中心的方法与监管要求同步，一直是A型肉毒毒素开发的核心。基于日益完善的PROs，对美容治疗综合益处的认识应不断提高。
