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Article History

Received: 7 April 2025

Accepted: 4 September 2025

First Online: 1 November 2025

Declarations

:

: Andrew F. Alexis received grants (funds to institution) from AbbVie, Amgen, Arcutis, Castle Biosciences, Dermavant, Galderma, Incyte, and LEO Pharma; served on advisory boards or as a consultant for AbbVie, Allergan, Almirall, Alphyn Biologics, Amgen, Apogee Therapeutics, Arcutis, AVITA Medical, Bausch Health, Beiersdorf, BMS, Boehringer Ingelheim, Canfield Scientific, Cara Therapeutics, Castle Biosciences, Cutera, Dermavant, EPI Health, Galderma, Genentech, Genzyme, Incyte, LEO Pharma, Lilly, L’Oreal, Janssen, Ortho Dermatologics, Pfizer, Sanofi Regeneron, Swiss American, UCB, and VisualDx; is a speaker for Aerolase, BMS, Janssen, Johnson & Johnson, L’Oreal, Regeneron, and Sanofi Genzyme; receives royalties from Elsevier, Wiley-Blackwell, and Wolters Kluwer Health; and received equipment from Aerolase. Michael Bukhalo is an investigator for Arcutis and received grants/research funding and honoraria. Fran E. Cook-Bolden serves as an advisory board member for AbbVie, Dermavant, Galderma, Novartis, Ortho Dermatologics, and Pfizer; as an investigator for Arcutis; as a speaker for Galderma, Journey Medical Corporation, and Ortho Dermatologics; and has received other financial benefit from Topix Pharmaceuticals. James Q. Del Rosso received investigator fees, speaker fees, clinical research grants, and/or honoraria from Aclaris, Almirall, Amgen, AnaptysBio, Arcutis, Athēnix, Biofrontera, BioPharmX, Biorasi, BlueCreek Dermatologics, BMS, Botanix, Brickell Biotech, Cara Therapeutics, Cassiopea SpA, Dermata, Dermavant, Dermira, Encore Dermatology, Evommune, Ferndale Laboratories, Foamix, Galderma, Genentech, Incyte, JEM Health, L’Oreal, La Roche-Posay, LEO Pharma, Lilly, Mayne Pharma, Menlo Therapeutics, Novan, Ortho Dermatologics, Pfizer, Promius Pharma, Ralexar, Regeneron, Sanofi Genzyme, Sebacia, Senté, Sol-Gel Technologies, Sonoma Pharmaceuticals, Sun Pharma, Trevi Therapeutics, UCB, Unilever Home & Personal Care, Verrica, and Viamet; and received salary as an employee of Regeneron. Zoe D. Draelos received a research grant from Arcutis to contribute to the study presented in the paper. Janet C. DuBois is an investigator for and receives grants/research funding from AbbVie, Accure for Acne, Acrotech Biopharma, Amplifica, Arcutis, Biofrontera, Bluefin Biomedicine, BMS, Brickell Biotech, Caliway Biopharmaceuticals, Cara Therapeutics, Cassiopea SpA, Croma-Pharma, Dermata, DermBiont, Incyte, Medytox, Merck, Moberg Pharma, Nail Genesis, Nielsen Biosciences, Q32 Bio, RAPT Therapeutics, Sanofi, Scarless Laboratories, TechnoDerma, Therapeutics Inc., and VeraDermics. Laura K. Ferris received consulting fees, investigator fees, speaker fees, clinical research grants, sponsored research, and/or honoraria from AbbVie, Amgen, Boehringer Ingelheim, BMS, Dermavant, Janssen, Lilly, Nimbus Therapeutics, Novartis, and UCB. Seth B. Forman is an investigator for Arcutis and received grants/research funding and honoraria. Steven E. Kempers is an investigator for Arcutis and received grants/research funding and honoraria. Leon H. Kircik received investigator fees, speaker fees, clinical research grants, and/or honoraria from 3M Pharmaceuticals, Abbott, Ablynx, Acambis, Allergan, Almirall, Amgen, AnaptysBio, Aqua Pharmaceuticals, Arcutis, Astellas, Asubio, Bayer Consumer Health, Beiersdorf, Biogen, Biolife, Biopelle, BMS, Boehringer Ingelheim, Botanix, Breckinridge Pharma, Cassiopea SpA, Celgene, Cellceutix, Centocor, ChemoCentryx, ColBar LifeScience, CollaGenex Pharmaceuticals, Connetics Corporation, Coria Laboratories, Dermavant, Dermik (a business of Sanofi Aventis), Dow Pharmaceutical Sciences, DUSA Pharmaceuticals, Embil Pharmaceutical Co, EOS Pharmaceutical Corp, Ferndale Laboratories, Galderma, Genentech, GSK, Healthpoint, Incyte, Intendis, ISDIN, Johnson & Johnson Consumer Products, Laboratory Skin Care, LEO Pharma, MC2 Therapeutics, Medical International Technologies, Medicis, Merck, Merck Serono, Merz Pharmaceuticals, NanoBio Corporation, Novartis, Nucryst, Obagi Medical, Onset Dermatologics, Ortho Dermatologics, Pfizer, Pharmaderm, Promius Pharma, PuraCap, QLT Inc., Sandoz (a Novartis company), SkinMedica, Stiefel (a GSK company), Sun Pharma, Taro Pharmaceuticals, TolerRx, Triax Pharmaceuticals, Valeant, Warner Chilcott, Xenoport, and Zalicus. Edward Lain is an investigator for Arcutis and received grants/research funding and honoraria. Angela Y. Moore received research funds or honoraria from AbbVie, Almirall, Arcutis, BMS, Cara Therapeutics, Dermavant, Galderma, Janssen, Incyte, Lilly, Novartis, Pfizer, Sanofi, Takeda, UCB, and Vyne. David M. Pariser is an investigator for and receives grants/research funding and/or honoraria from Almirall, Amgen, AOBiome, Asana BioSciences, Brickell Biotech, Celgene, Dermira, LEO Pharma, Lilly, Menlo Therapeutics, Novartis, Novo Nordisk, Ortho Dermatologics, Pfizer, and Regeneron; is a consultant and/or serves on an advisory board for and receives honoraria from Biofrontera, Brickell Biotech, Dermira, Novartis, Pfizer, Regeneron, and Sanofi; and is on the data safety monitoring board and receives honoraria from BMS. Joseph Raoof has served as an investigator for AbbVie, Arcutis, AstraZeneca, Bausch Health, BMS, Boehringer Ingelheim, Dermavant, Dermira, Galderma, GSK, Incyte, Janssen, LEO Pharma, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and UCB. Matthew J. Zirwas received consulting fees, investigator fees, speaker fees, clinical research grants, and/or honoraria from and/or has participated in sponsored research for AbbVie, All Free Clear/Sun, AnaptysBio, Arcutis, Asana Biosciences, Aseptic MD, Avillion, Bausch Health, Cara Therapeutics, Concert Pharmaceuticals, Dermavant, Edesa, EPI Health, Fitbit, Galderma, Genentech/Novartis, Incyte, Janssen, L’Oreal, LEO Pharma, Level Ex, Lilly, LUUM, Oculus, Peloton, Pfizer, Sanofi Regeneron, Sol-Gel Technologies, Trevi Therapeutics, UCB, and Vyne. Melissa S. Seal, Saori Kato, David H. Chu, David Krupa, Scott Snyder, Patrick Burnett, and David R. Berk are employees of Arcutis.

: Data collected for this study will be made available to others. Proposals for data requests will be reviewed and considered for sharing following approval of the indication.

: Not applicable.

: The protocol was approved by the WCG Institutional Review Board (IRB Tracking Number: 20201067), and local institutional review boards for sites not covered by this central institutional review board. The trial was conducted in accordance with the principles of the 1964 Declaration of Helsinki and its later amendments, with the exception that this trial was retrospectively registered. The trial was posted to clinicaltrials.gov no later than 21 days after enrollment of the first participant in accordance with the Food and Drug Administration Amendments Act (FDAAA) 801 guidance.

: Written informed consent was obtained from all patients at screening prior to trial enrollment; assent was also obtained when applicable.

: The investigators obtained written consent from patients for their photographs and medical information to be published in print and online with the understanding that this information may be publicly available. Patient consent forms were not provided to the journal but were retained by the investigators.

: Andrew F. Alexis had full access to all data in the trial and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Seal, Kato, Chu, Krupa, Snyder, Burnett, and Berk. Acquisition, analysis, or interpretation of data: all authors. Drafting of the manuscript: all authors. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: Krupa. Supervision: Seal, Kato, Chu, Krupa, Snyder, Burnett, and Berk. All authors read and approved the final manuscript.