Funding for this research was provided by:
Arcutis Biotherapeutics, Inc.
Accepted: 16 October 2022
First Online: 12 November 2022
: This work was supported by Arcutis Biotherapeutics, Inc.
: The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines of the International Council for Harmonisation and is registered on ClinicalTrials.gov (NCT03638258). Reviewed and approved by the Aspire Institutional Review Board for US sites, the Western Institutional Review Board for sites in Canada, and local institutional review boards for sites not covered by these central institutional review boards.
: L. Stein Gold is an investigator for AbbVie, Arcutis, Amgen, Dermavant, Eli Lilly and Company, Leo, Novartis, Ortho Derm, and Pfizer; serves as an advisor for Amgen, Arcutis, BMS, Dermavant, Leo, Novartis, Ortho Derm, Pfizer, and UCB, is a speaker for Amgen, Leo, Ortho Derm, and Pfizer. J. Alonso-Llamazares is an investigator for Arcutis; speaker for Celgene (Amgen), Dermira (Eli Lilly), Eli Lilly and Company, Ortho Derm, and UCB Pharma; and serves on advisory boards for Leo. Z.D. Draelos received grant support from Arcutis Biotherapeutics, Inc. for the conduct of this study. M.J. Gooderham has been a speaker, advisory board member, investigator and/or consultant for AbbVie, Akros, Amgen, Arcutis, BMS, Boehringer-Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, and Valeant/Bausch. S.E. Kempers is an investigator for Arcutis Biotherapeutics, Inc., and serves as a consultant for Foamix and Kinex. L.H. Kircik is an investigator, consultant, speaker, and/or advisory board member for Abbott Laboratories, Acambis, Aclaris, Allergan, Inc., Almirall, Amgen Inc., Anacor Pharmaceuticals, Assos Pharma, Astellas Pharma US, Inc., Asubio, Berlex Laboratories (Bayer HealthCare Pharmaceuticals), Biogen-Idec, Biolife, Biopelle, Boehringer-Ingelheim, Breckinridge Pharma, Celgene, Cellceutix, Centocor, Inc., Cipher, Coherus, Colbar, CollaGenex, Combinatrix, Connetics Corporation, Coria, Dermavant, Dermik Laboratories, Dermira, Dow Pharmaceutical Sciences, Inc., Dusa, Eli Lilly and Company, Embil Pharmaceuticals, EOS, Exeltis, Ferndale Laboratories, Inc., Foamix, Genentech, Inc., GlaxoSmithKline, PLC, Health Point, LTD, Idera, Innocutis, Innovail, Intendis, Isdin, Johnson & Johnson, Laboratory Skin Care Inc., Leo, L'Oreal, 3M, Maruho, Medical International Technologies, Medicis Pharmaceutical Corp., Merck, Merz, Nano Bio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp., Obagi, Onset, OrthoNeutrogena, PediaPharma, PharmaDerm, Pfizer, Promius, PuraCap, QLT, Inc., Quinnova, Quatrix, Serono (Merck Serono International SA), SkinMedica, Inc., Stiefel Laboratories, Inc., Sun Pharma, Taro, TolerRx, Triax, UCB Pharma, Valeant Pharmaceuticals Intl, Warner-Chilcott, XenoPort, and ZAGE. M.G. Lebwohl reports receipt of research funds from AbbVie, Amgen, Arcutis, Boehringer-Ingelheim, Dermavant, Eli Lilly and Company, Incyte, Janssen Research & Development, LLC, Leo Pharma, Ortho Dermatologics, Pfizer, and UCB Pharma and serves as a consultant for Aditum Bio, Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., BMD Skincare, Boehringer-Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica. K.A. Papp is an investigator, consultant, speaker, scientific officer or has served on steering committees or advisory boards for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health/Valeant, Baxalta, Boehringer-Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly and Company, Evelo, Galapagos, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, UCB, and Xencor. D.M. Pariser is an investigator, consultant, and/or advisory board member for Abbott Laboratories, Almirall, Amgen, AOBiome, LLC, Asana Biosciences, LLC, Atacama Therapeutics, Bickel Biotechnology, Biofrontera AG, BMS, Celgene Corporation, Dermavant Sciences, Dermira, Eli Lilly and Company, LEO Pharma, US, Menlo Therapeutics, Merck & Co., Inc, Novartis Pharmaceuticals Corp., Novo Nordisk A/S, Ortho Dermatologics, Pfizer Inc., Regeneron, Sanofi, Stiefel, a GSK company, TDM SurgiTech, Inc., TheraVida, and Valeant Pharmaceuticals International. D.P. Toth is an investigator and/or consultant for AbbVie, Amgen, Arcutis, Avillion, Bausch Health/Valeant, Bristol Myers Squibb, Boehringer-Ingelheim, Celgene, Dermira, Eli Lilly and Company, Galderma, Genentech, GSK, Incyte, Janssen, Leo Pharma, Merck Serono, Medimmune, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, and UCB Pharma. G. Yosipovitch has received grant/research support from Bellus Health, Galderma, Kiniksa, Leo Pharma, Novartis, Pfizer Inc., and Sanofi Regeneron and has been a consultant for Bellus Health, Eli Lilly and Company, Galderma, Kiniksa, Leo Pharma, Novartis, Pfizer Inc., Sanofi Regeneron, and Trevi. R. Higham, A. Feng, and D.R. Berk are employees of Arcutis Biotherapeutics, Inc.
: Before enrollment of patients, the study protocol and informed consent form were reviewed and approved by an appropriate Institutional Review Board or Independent Ethics Committee. All patients provided written informed consent before screening.
: Not applicable.
: 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. Information about when data availability will begin and end will be provided following approval of the indication.
: Authors had full access to all the data in the study and they all take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: All authors. 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: Feng. Supervision: Higham, Berk.