Document is current

Article History

Received: 24 September 2025

Accepted: 17 February 2026

First Online: 28 March 2026

Declarations

:

: Amy S. Paller has served as an investigator, consultant, and/or data and safety monitoring board member for AbbVie, Abeona, Arcutis, BioCryst, BioMendics, Boehringer Ingelheim, Castle Creek, Chiesi, Daiichi Sankyo, Dermavant, Eli Lilly, Galderma, Incyte, Johnson & Johnson Innovative Medicine, Krystal, LEO, L’Oréal, MoonLake Immunotherapeutics, Pelthos, Quoin, Regeneron Pharmaceuticals Inc., and Sanofi. Amy S. Paller is an Editorial Board member of the American Journal of Clinical Dermatology. Amy S. Paller was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Eric L. Simpson has served as a principal investigator for and/or received grants or personal fees from AbbVie, Acrotech, Amgen, Arcutis, ASLAN, Astria Therapeutics, Castle, CorEvitas, Dermavant, Dermira, Eli Lily, FIDE, Impetus Healthcare, Incyte, Innovaderm Recherches/Indero, Janssen, LEO, Numab Therapeutics AG, Pfizer, Recludix Pharma, Regeneron Pharmaceuticals Inc., Roche Products Ltd, Sanofi, Sitryx Therapeutics, Target, and Veriskin. Elaine C. Siegfried has served as a speaker, consultant, researcher, data and safety monitoring board member, principal investigator, and/or scientific advisory committee member for AbbVie, AI Therapeutics, Amgen, ASLAN Pharmaceuticals, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, LEO Pharma, National Eczema Association, National Foundation for Ectodermal Dysplasias, Novan, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals Inc., Sanofi, UCB, and Verrica Pharmaceuticals; received grant 2020–2022 as Pfizer Pediatric Dermatology Fellow. Michael J. Cork has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, support for attending meetings and/or travel, fees for participation on a data safety monitoring board or advisory board, research grants, and/or consulting fees from Hyphens Pharma, Johnson & Johnson, LEO Pharma, L’Oréal, Perrigo (ACO Nordic), Pfizer, Procter & Gamble, Regeneron Pharmaceuticals Inc., and Sanofi, and has served as a voluntary medical advisor for National Eczema Society, UK. Peter D. Arkwright has received honoraria for consulting services and/or study support from AbbVie, Aslan Pharmaceuticals, BMS, Castle Biosciences, Dermavant, Eli Lilly, Forté, Galderma, Incyte, Janssen, L’Oréal, MatriSys Bioscience, Menlo Therapeutics, Novartis, Otsuka, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and Valeant/Ortho Dermatologics. Andreas Pinter has worked on clinical trials and/or received speaker fees and/or grants from 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. Mette Deleuran has received research support/consulting/advisory board agreements, travel support, and/or honoraria for lectures from AbbVie, Almirall, Eli Lilly, Incyte, Kymab, La Roche-Posay, LEO Pharma, Mustela, Numab Therapeutics AG, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals Inc., Sanofi, and UNION Therapeutics. H. Chih-ho Hong has served as investigator, consultant, and/or speaker for AbbVie, Amgen, Bausch Health, BMS, Boehringer Ingelheim, Centocor, Cipher Pharmaceuticals, Cutanea, Dermavant, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, MedImmune, Novartis, Regeneron Pharmaceuticals Inc., Roche, and Sanofi. Yonghao Ma, Ashish Bansal, and Tien V. Nguyen are employees and shareholders of Regeneron Pharmaceuticals Inc. Ariane Dubost-Brama is an employee 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, etc.) 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 reidentification. 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 Electronic Supplementary Material (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.

: Tien Nguyen, Ariane Dubost-Brama and Ashish Bansal designed the study. Amy Paller, Eric Simpson, Elaine Siegfried, Michael Cork, Peter Arkwright, Andreas Pinter, and H. Chih-Ho Hong acquired data. Yonghao Ma 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.