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Article History

Received: 17 November 2025

Accepted: 5 March 2026

First Online: 2 April 2026

Declarations

:

: Amy S. Paller has served as investigator for AbbVie, BioMendics, Dermavant, Eli Lilly, Incyte, Johnson & Johnson Innovative Medicine, Regeneron Pharmaceuticals Inc., and UCB; consultant for Abeona, Arcutis, BioCryst, Boehringer Ingelheim, Castle Creek, Chiesi, Dermavant, Johnson & Johnson Innovative Medicine, Krystal, LEO, Lilly, L’Oréal, MoonLake Immunotherapeutics, Pelthos, Quoin, Regeneron Pharmaceuticals Inc., and Sanofi; and as a data safety monitoring board member for AbbVie, Abeona, BioCryst, Daiichi Sankyo, and Galderma. Andreas Pinter has conducted clinical trials for AbbVie, Almirall Hermal, Amgen, Biogen Idec, BioNTech, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Galderma, GSK, Hexal, Janssen, Klinge Pharma, LEO Pharma, MC2 Pharma, Medac, Merck Serono, Mitsubishi Tanabe Pharma, MSD, Novartis, Pascoe, Pfizer, Regeneron Pharmaceuticals Inc., Roche, Sandoz, Sanofi, Schering-Plough, Tigercat Pharma, UCB Pharma, and Zuellig Pharma; received speaker fees from AbbVie, Almirall Hermal, Amgen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Galderma, Janssen, Klinge Pharma, LEO Pharma, Medac, Novartis, Pfizer, Sanofi, UCB Pharma, and Zuellig Pharma; and grants from AbbVie and Almirall. Lara Wine Lee has served as an advisory board member for Castle Creek Biosciences, Chiesi, Eli Lilly, Pfizer, Regeneron Pharmaceuticals Inc., TWi Biotechnology, and Verrica; consultant for AbbVie, Apogee, Chiesi, Eli Lilly, Kimberly-Clark, Krystal Biotech, and Novartis; investigator for AbbVie, Amgen, Amryt Pharma, Apogee, Arcutis Biotherapeutics, Boehringer Ingelheim, Castle Creek Biosciences, Celgene, Eli Lilly, Galderma, Incyte, LEO Pharma, Mayne Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, Target Pharma, Trevi Therapeutics, TWi Biotechnology, and UCB; speaker for Chiesi, Krystal Biotech, and Sanofi; and as a data safety monitoring board member for BMS. Ronald Aschoff has been a speaker for AbbVie, Almirall Hermal, Biofrontera, BMS, Boehringer Ingelheim, BSN medical, Galderma, Incyte, Janssen-Cilag, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, and UCB; and a consultant with honorarium for Almirall Hermal, Janssen-Cilag, and LEO Pharma. Jacek Zdybski served as an investigator for Almirall, Amgen, BMS, Galderma, Incyte, Innovaderm, Pfizer, Regeneron Pharmaceuticals Inc., and Syneos Health. Christina Schnopp has conducted clinical studies for Benevi, Novartis, and Sanofi; has been a lecturer at educational events for AbbVie, Amgen, Galderma, InfectoPharm, La Roche-Posay, LEO Pharma, LETI Pharma, Lilly, MSD, Nestlé, Novartis, and Pierre Fabre; and has served as a consultant for Lilly, Novartis, Pierre Fabre, and Sanofi. Faisal A. Khokhar, Ashish Bansal, and Brad Shumel are employees and shareholders of Regeneron Pharmaceuticals Inc. Amy H. Praestgaard and Mike Bastian are employees of and may hold stock and/or stock options in Sanofi.

: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing 1) once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA) or development of the product has been discontinued globally for all indications on or after April 2020 and there are no plans for future development; 2) if there is legal authority to share the data; and 3) there is not a reasonable likelihood of participant re-identification. Submit requests to .

: The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guideline, and applicable regulatory requirements. An independent data and safety monitoring committee conducted blinded monitoring of patient safety data. The local institutional review board (IRB) or ethics committee (EC) at each study center oversaw trial conduct and documentation. A list of IRB/EC approval numbers for each participating site is provided in the Supplementary Information (Appendix S2).

: All patients, or their parents/guardians, provided written informed consent before participating in the trial. Pediatric patients provided assent according to the ethics committee (institutional review board/independent ethics committee)-approved standard practice for pediatric patients at each participating center.

: Not applicable.

: Not applicable.

: Mike Bastian, Brad Shumel, and Ashish Bansal designed the study. Amy Paller, Andreas Pinter, Lara Wine Lee, Roland Aschoff, Jacek Zdybski, and Christina Schnopp acquired data. Amy Praestgaard conducted the statistical analyses of the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript.