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Article History

Accepted: 29 March 2023

First Online: 15 May 2023

Declarations

:

: This study was funded by Pfizer Inc., New York, NY, USA.

: LFE has served as a scientific advisor, consultant, and/or clinical study investigator for Pfizer Inc., AbbVie, Almirall, Amgen, Arena, Aslan Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Otsuka, Regeneron, and Sanofi-Genzyme. RGG has received research grants for Pfizer Inc. crisaborole clinical trials and consulting fees for participating on the Pfizer crisaborole advisory board as well as research grants from LEO Pharma and Incyte as an investigator. JX has received honoraria for serving as a speaker for Pfizer Inc., Novartis, and Sanofi. MSA has received research grants for her role as an investigator for AbbVie, Janssen, Novartis, and UCB; has received honoraria for serving on advisory boards for AbbVie, Novartis, and UCB; and has received honoraria for serving as a speaker for AbbVie. JCS has been a consultant/speaker/investigator for Pfizer Inc., AbbVie, Amgen, Bioderma, Bristol Myers Squibb, Ego Pharmaceuticals, Eli Lilly and Company, Janssen, LEO Pharma, L’Oreal, Mayne, Novartis, Pierre-Fabre, and Sanofi. DEM, PS, BV, CZ, JL, and JW are employees and shareholders of Pfizer Inc.

: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See for more information.

: The final protocol, any amendments, and informed consent/assent documentation were reviewed and approved by the institutional review boards or institutional ethics committees at each of the investigational centers participating in the study. All patients or parent(s)/guardian(s) provided written informed consent, including age-appropriate assent, for participation in the study. This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines.

: Informed consent and age-appropriate assents were obtained from all individual participants included in the study and/or their caregivers.

: Not applicable.

: Not applicable.

: All the authors were involved in the interpretation of the data, the draft preparation, writing, and approval of the final manuscript for submission. LFE, RG, JX, MSA, and JCS were involved in the methodology and investigation of the study. DEM, PS, BV, JL, and JW were involved in the conceptualization, methodology, formal analysis and investigation, and supervision of the study. CZ was involved in the conceptualization, methodology, and statistical analysis of the data.