Funding

This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc., ClinicalTrials.gov Identifier: NCT03687359. The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication.

Conflicts of Interest

Amy S. Paller is an investigator for AbbVie, Applied Pharma Research, Dermavant, Eli Lilly, Incyte, Janssen, Krystal Biotech, Regeneron Pharmaceuticals Inc., and UCB; a consultant for Aegerion Pharmaceuticals, Azitra, BioCryst, Boehringer Ingelheim, BMS, Eli Lilly, Janssen, Johnson & Johnson, Krystal Biotech, LEO Pharma, Novartis, Primus Pharmaceuticals, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWi Biotechnology, and UCB; and participates on data safety monitoring boards for AbbVie, Abeona Therapeutics, Catawba Research, Galderma, and InMed Pharmaceuticals. Amy S. Paller is an Editorial Board member of the American Journal of Clinical Dermatology. Amy Paller was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Danielle Marcoux is an advisory board member for Arcutis Biotherapeutics, Johnson & Johnson, Pierre Fabre, and Sanofi; is a consultant for AbbVie, Novartis, and Sanofi; an investigator for AbbVie, Amgen, Celgene, Eli Lilly, Incyte, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and UCB; and a speaker for LEO Pharma, Pfizer, and Sanofi. Michele Ramien is a consultant for AbbVie, Eli Lilly, LEO Pharma, Pfizer, and Sanofi; and participates in a registry study for Sanofi. Eulalia Baselga is a speaker for Almirall; an investigator for AbbVie, Eli Lilly, and Pfizer; an investigator and consultant for Pierre Fabre Dermatologie; a consultant for Regeneron Pharmaceuticals Inc. and Sanofi; and a co-founder and consultant for Venthera. Vania Oliveira de Carvalho is a speaker for Expanscience, Galderma, Johnson & Johnson Consumer Health, Mantecorp Skincare, Megalabs, and Royal Canin; and an investigator for Sanofi. Ledit R.F. Ardusso is a consultant and/or advisory board member, and/or speaker for AstraZeneca, GSK, Novartis, and Sanofi. Marlies De Graaf is an investigator for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi; a consultant for AbbVie, Almirall, Eli Lilly, LEO Pharma, Regeneron Pharmaceuticals Inc., and Sanofi; and a speaker for AbbVie, Eli Lilly, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. Suzanne Pasmans is an advisor, consultant, speaker, and/or investigator for Boehringer Ingelheim, LEO Pharma, Novartis, Pierre Fabre, Regeneron Pharmaceuticals Inc., and Sanofi; and has received grants from BAP Medical, Boehringer Ingelheim, D&M, DeclaCare (part of BENU Netherlands), Micreos, Ministry of Health Welfare and Sport, Novartis, Pierre Fabre, and Zon MW. Mirna Toledo-Bahena is a speaker for AbbVie, Expanscience, Janssen, LEO Pharma, and Pierre Fabre; and an investigator for Pfizer and Sanofi. Cory Rubin is a speaker for AbbVie, Amgen, Bayer, BMS, Castle Creek Biosciences, Celgene, Cutanea, Dermavant, DermTech, Galderma, Genentech, Helsinn, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Promius Pharma, Regeneron Pharmaceuticals Inc., Sanofi, Sun Pharma, and UCB; a consultant for AbbVie, Allergan, Amgen, Biofrontera, Castle Creek Biosciences, Celgene, Dermavant, DermTech, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Promius Pharma, Regeneron Pharmaceuticals Inc., Sanofi, and UCB; and an investigator for BMS, Cara Therapeutics, Castle Creek Biosciences, DermTech, Janssen, LEO Pharma, and Sanofi. Joel C. Joyce has received consultant fees from Pfizer and Sanofi; speaker fees from Sanofi; and is a study investigator for AbbVie, Aclaris Therapeutics, Amgen, AstraZeneca, Bayer, BMS, Eli Lilly, Galderma, Incyte, Janssen, NFlection Therapeutics, Novartis, Pfizer, Sanofi, and UCB. Lara Wine Lee is an advisory board member for Castle Creek Biosciences, Eli Lilly, Pfizer, and Regeneron Pharmaceuticals Inc; is a consultant for AbbVie, Amryt Pharma, Kimberly-Clark, Krystal Biotech, Novartis, and Pyramid Biosciences; an investigator with AbbVie, Amgen, Amryt Pharma, Arcutis Biotherapeutics, Castle Creek Biosciences, Celgene, Eli Lilly, Galderma, Incyte, Mayne Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, Target Pharma, Trevi Therapeutics, and UCB; and a speaker for Amryt Pharma and Krystal Biotech. Rajan Gupta has served as a consultant for Sanofi. Bryan Adams and Annie Zhang are employees of Sanofi and may hold stock and/or stock options in the company. Marius Ardeleanu is an employee and shareholder of Regeneron Pharmaceuticals Inc.

Data Availability

Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication have been approved by major health authorities (e.g., FDA, EMA, PMDA), if there is legal authority to share the data, and there is not a reasonable likelihood of participant re-identification. Submit requests to https://vivli.org/.

Ethics Approval

This study was conducted in accordance with the ethical standards of the responsible committees and with the Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice. The trial was overseen by an independent data and safety monitoring board. The protocol was reviewed and approved by institutional review boards/ethics committees at all centers.

Authors’ Contributions

Amy S. Paller and Annie Zhang contributed to the study concept and design. Ledit R.F. Ardusso, Vania Oliveira Carvalho, Danielle Marcoux, Michelle Ramien, Mirna Toledo-Bahena, Suzanne Pasmans, Marlies de Graaf, Joel C. Joyce, Cory Rubin, and Lara Wine Lee contributed to data acquisition. Rajan Gupta and Bryan Adams 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.

Informed Consent

Written informed consent was obtained from all patients or their proxies.

Consent to Participate

Written informed consent was obtained from all patients or their proxies.

Consent for Publication

Not applicable.

Code Availability

Not applicable.