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Competing Interests: Conflicts of interest Mr Sood, Mr Rimke, Dr Rankin, Dr Abduelmula, Dr Georgakopoulos, Dr Maliyar, and Mr. Bagit have no relevant disclosures. Ms. Fernejoy Leung has been an advisor, consultant, speaker and/or investigator for AbbVie, Arcutis, Bausch Health, BioScript Solutions, Incyte, Janssen, LEO Pharma, Novartis, and UCB. Ms Lauren A. Stark has been an advisor, consultant, speaker and/or investigator for AbbVie, Arcutis, BioScript Solutions, Janssen, and Novartis.Dr Alim R. Devani has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, Tribute, UCB, and Valeant. Dr Ronald Vender has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, Aralez, Arcutis, Astellas, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Centocor, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Innovaderm, Janssen, Kabi-Care, LEO Pharma, Merck, Novartis, Palladin, Pfizer, Regeneron, Sandoz, Sun Pharma, Takeda, UCB, and Viatris-Mylan. Dr Jensen Yeung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Anacor, Arcutis, Astellas, Bausche, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Coherus, Dermira, Forward, Fresenius Kabi, Galderma, Incyte, Janssen, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB, and Xenon. Dr Vimal H. Prajapati has been an advisor, consultant, and/or speaker for AbbVie, Actelion, Amgen, Apogee Therapeutics, Aralez, Arcutis, Aspen, Bausch Health/Valeant, BioScript Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Canadian Psoriasis Network, Celgene, Cipher, Concert, CorEvitas, Eczema Society of Canada, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, Janssen, LEO Pharma, Medexus, Novartis, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, and UCB; investigator for AbbVie, AnaptysBio, Arcutis, Arena, Asana, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nektar Therapeutics, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, RAPT Therapeutics, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; received grants from AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme.

Competing Interests: Conflicts of interest Dr Leung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Arcutis, Bausch Health, BioScript Solutions, Incyte, Janssen, LEO Pharma, Novartis, and UCB. Dr Devani has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, Tribute, UCB, and Valeant. Dr Vender has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, Aralez, Arcutis, Astellas, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Centocor, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Innovaderm, Janssen, Kabi-Care, LEO Pharma, Merck, Novartis, Palladin, Pfizer, Regeneron, Sandoz, Sun Pharma, Takeda, UCB, and Viatris-Mylan. Dr Yeung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Anacor, Arcutis, Astellas, Bausche, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Coherus, Dermira, Forward, Fresenius Kabi, Galderma, Incyte, Janssen, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB, and Xenon. Dr Prajapati has been an advisor, consultant, and/or speaker for AbbVie, Actelion, Amgen, Apogee Therapeutics, Aralez, Arcutis, Aspen, Bausch Health/Valeant, BioScript Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Canadian Psoriasis Network, Celgene, Cipher, Concert, CorEvitas, Eczema Society of Canada, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, Janssen, LEO Pharma, Medexus, Novartis, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, and UCB; investigator for AbbVie, AnaptysBio, Arcutis, Arena, Asana, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Meiji Pharma, Nektar Therapeutics, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, RAPT Therapeutics, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; received grants from AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme. Drs Sood, Rimke, Rankin, Abduelmula, Georgakopoulos, Maliyar, and Bagit have no conflicts of interest to declare.

Generalized pustular psoriasis (GPP) is a rare, immune-mediated inflammatory disease with characteristic cutaneous and systemic manifestations. Mutations in the interleukin-36 receptor antagonist (IL36RN) gene have been implicated in its pathogenesis. Spesolimab is a novel systemic biologic therapy that selectively inhibits interleukin-36. It was recently approved by Health Canada and the US FDA for the treatment of GPP flares in adults. Results from phase 1 and 2 studies have been promising. Herein, we review the efficacy and safety of spesolimab for the treatment of GPP flares, as demonstrated in clinical trials., Competing Interests: Ronald Vender has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, Aralez, Arcutis, Astellas, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Centocor, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Innovaderm, Janssen, Kabi-Care, LEO Pharma, Merck, Novartis, Palladin, Pfizer, Regeneron, Sandoz, Sun Pharma, Takeda, UCB, and Viatris-Mylan. Jensen Yeung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Allergan, Amgen, Astellas, Boehringer Ingelheim, Celgene, Centocor, Coherus, Dermira, Eli Lilly, Forward, Galderma, GSK, Janssen, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB, Valeant, and Xenon. Alim R. Devani has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, Tribute, UCB, and Valeant. Vimal H. Prajapati has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, AnaptysBio, Apogee Therapeutics, Aralez, Arcutis, Arena, Asana, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Concert, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Homeocan, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, RAPT Therapeutics, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, Tribute, UCB, and Valeant. Tuba Bukhari, Mariya Markovina, Abrahim Abduelmula, and Brian D. Rankin have no relevant disclosures. Funding sources: None.

Background: Scalp psoriasis affects most patients with psoriasis, but it can be difficult to treat., Objectives: To evaluate the efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis., Methods: In a phase IIb randomized controlled trial, adults and adolescents aged ≥ 12 years with scalp and body psoriasis were randomized (2 : 1) to roflumilast foam 0.3% or vehicle for 8 weeks. The primary efficacy endpoint was scalp Investigator Global Assessment (S-IGA) success (score of 'clear' or 'almost clear' plus ≥ 2-grade improvement from baseline) at week 8. Safety and tolerability were also evaluated., Results: Significantly more roflumilast-treated patients (59.1%) than vehicle-treated patients (11.4%) achieved S-IGA success at week 8 (P < 0.001); differences favoured roflumilast as early as the first postbaseline visit at week 2 (P < 0.001). Significant improvements were also seen for secondary endpoints, including body IGA success, Scalp Itch Numeric Rating Scale and the Psoriasis Scalp Severity Index. The safety of roflumilast was generally similar to vehicle. Patients treated with roflumilast experienced low rates of treatment-emergent adverse events (AEs), with few discontinuations due to an AE. Few patients with skin of colour (11%) and few adolescents (0.7%) were included., Conclusions: The results support the further development of roflumilast foam for treating scalp and body psoriasis., Competing Interests: Conflicts of interest: L.H.K. has received investigator fees, speaker fees, clinical research grants and/or honoraria from Abbott Laboratories, Ablynx, Acambis, Allergan, Almirall, Amgen, AnaptysBio, Aqua, Arcutis, Astellas Pharma US, Asubio Pharmaceuticals, Bayer Consumer Healthcare Pharmaceuticals, Beiersdorf, Biogen, BioLife, Biopelle, Boehringer Ingelheim, Botanix Pharmaceuticals, Breckenridge Pharma, Bristol Myers Squibb, Cassiopea, Celgene, Cellceutix, Centocor Ortho Biotech, ChemoCentryx, CollaGenex Pharmaceuticals, ColBar LifeScience, Connetics Corporation, Coria Laboratories, Dermavant Sciences, Dermik Laboratories (a business of Sanofi-Aventis US), Dow Pharmaceutical Sciences, DUSA Pharmaceuticals, Embil Pharmaceutical, EOS, Ferndale Laboratories, Galderma Laboratories, Genentech, GlaxoSmithKline, Healthpoint, Incyte Corporation, Intendis, Isdin, Johnson & Johnson Consumer Products Company, Laboratory Skin Care, LEO Pharma, 3M Pharmaceuticals, MC2 Therapeutics, Medical International Technologies, Medicis Pharmaceutical, Merck & Co., Merck-Serono, Merz Pharmaceuticals, NanoBio Corporation, Novartis Pharmaceuticals, Nucryst, Obagi Medical Products, Ortho Dermatologics, Onset Dermatologics, Pfizer, PharmaDerm, Promius Pharma, PuraCap Pharmaceutical, QLT, Sandoz (a Novartis company), SkinMedica, Stiefel Laboratories (a GSK company), Sun Pharmaceutical Industries, Taro Pharmaceutical Industries, TolerRx, Triax Pharmaceuticals, Valeant Pharmaceuticals International, Warner Chilcott, XenoPort and Zalicus. J.A.-L. is an investigator for Arcutis Biotherapeutics; a speaker for Celgene (Amgen), Dermira (Eli Lilly), Eli Lilly, Ortho Dermatologics and UCB Pharma; and serves on advisory boards for LEO Pharma. N.B. is an advisor, consultant and investigator for Arcutis Biotherapeutics, and received grants/research funding and honoraria. M.B. is an investigator for Arcutis Biotherapeutics, and received grants/research funding and honoraria. A.R.D. has received investigator fees, speaker fees and/or honoraria from AbbVie, Amgen, Arcutis Biotherapeutics, Bausch Health/Valeant Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant Sciences, Dermira, Eli Lilly, Galapagos, Galderma Laboratories, GSK, Incyte Corporation, Janssen Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Reistone Biopharma, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda and UCB Pharma. Z.D.D. received a research grant from Arcutis Biotherapeutics to contribute to the data presented in the paper. J.D. is an investigator for and receives grants/research funding from AbbVie, AiViva BioPharma, Allergan, Almirall, AnaptysBio, Arcutis Biotherapeutics, Bausch Health, Bellus Medical, Biofrontera, Brickell Biotech, Bristol Myers Squibb, Caliway Biopharmaceuticals, Cara Therapeutics, Croma-Pharma, Dermata Therapeutics, DermBiont, Dr. Reddy’s Laboratories, Endo Pharmaceuticals, Evommune, Galderma USA, Hexima, Incyte Corporation, LEO Laboratories (LEO Pharma), Merck, NFlection Therapeutics, Palvella Therapeutics, RAPT Therapeutics and Therapeutics; is an advisory board member for and receives honoraria from RAPT Therapeutics; and is an independent contractor for and receives other financial benefit from Vial Health Technology. M.J.G. has received investigator fees, speaker fees and/or honoraria from AbbVie, Akros, Amgen, AnaptysBio, Arcutis Biotherapeutics, Aristea Therapeutics, Aslan Pharmaceuticals, Bausch, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Dermavant Sciences, Dermira, Eli Lilly, Galderma Laboratories, GSK, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Kirin International, MedImmune, Meiji Seika Pharma, Merck, MoonLake Immunotherapeutics, Nimbus Therapeutics, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sun Pharma and UCB Pharma. S.E.K. declares no conflicts of interests. E.L. is an investigator for Arcutis Biotherapeutics, and has received grants/research funding and honoraria. M.L. is an investigator for AbbVie, Arcutis Biotherapeutics, AstraZeneca, Bausch Health, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Dermavant Sciences, Dermira, Eli Lilly, Incyte Corporation, Janssen Pharmaceuticals, Kiniksa Pharmaceuticals, LEO Pharma, Pfizer, RAPT Therapeutics, Reistone Biopharma, Regeneron Pharmaceuticals and UCB Biopharma. A.M. is an investigator for and has received research funds or honoraria from AbbVie, Arcutis Biotherapeutics, Bristol Myers Squibb, Dermavant Sciences, Eli Lilly, Galderma Laboratories, Janssen Pharmaceuticals and Nimbus Therapeutics. D.F.M. is an advisory board member/investigator for Almirall, Amicus Therapeutics, Amgen, Amryt Pharma, AnaptysBio, Arcutis Biotherapeutics, Arena Pharmaceuticals, ArgenX, AstraZeneca, Azora Therapeutics, Castle Creek Biosciences, Dermira, Eli Lilly, Evelo Biosciences, Factor Bioscience, Galderma Laboratories, Innovaderm Research, Janssen Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Principia Biopharma, Regeneron Pharmaceuticals, Rheacell, Sanofi, Shire, Sienna Biopharmaceuticals, Sun Pharma, UCB Pharma and Xerion Healthcare. K.A.P. has received investigator fees, speaker fees, clinical research grants and/or honoraria from AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Arcutis Biotherapeutics, Astellas Pharma US, Avillion, Bausch Health/Valeant Pharmaceuticals International, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite BioPharma, Celgene, Celltrion Healthcare, Coherus Biosciences, Dermavant Sciences, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Forbion, Galapagos, Galderma Laboratories, Genentech, Gilead, GSK, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Hakko Kirin, LEO Pharma, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron Pharmaceuticals, Reistone Biopharma, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB Pharma, vTv Therapeutics and Xencor. D.M.P. is an investigator for and receives grants/research funding and/or honoraria from Almirall, Amgen, AOBiome, Asana BioSciences, Bickel Biotechnology, Celgene Corporation, Dermira, Eli Lilly and Company, LEO Pharma, Menlo Therapeutics, Novartis Pharmaceuticals, Novo Nordisk, Ortho Dermatologics, Pfizer and Regeneron Pharmaceuticals; is a consultant for and/or serves on an advisory board for and receives honoraria from Bickel Biotechnology, Biofrontera, Dermira, Novartis Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals and Sanofi; and is on the Data Safety Monitoring Board for and receives honoraria from Bristol Myers Squibb. R.S. is an investigator for Arcutis Biotherapeutics and received grants/research funding and honoraria. M.Z. has received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, All Free Clear/Sun, AnaptysBio, Arcutis Biotherapeutics, Asana BioSciences, Aseptic, Avillion, Bausch Health, Cara Therapeutics, Concert Pharmaceuticals, Dermavant Sciences, Edesa Biotech, Eli Lilly, EPI Health, Fitbit, Galderma Laboratories, Genentech/Novartis, Incyte Corporation, Janssen Pharmaceuticals, LEO Pharma, Level Ex, L’Oréal, LUUM, Oculus, Peloton, Pfizer, Regeneron Pharmaceuticals/Sanofi, Sol-Gel, Trevi Therapeutics, UCB Pharma and VYNE Therapeutics. P.B., R.C.H., D.K. and D.R.B. are employees of Arcutis Biotherapeutics. This work was supported by Arcutis Biotherapeutics., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Competing Interests: Conflicts of interest Dr Devani has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, Tribute, and UCB. Dr Prajapati has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, AnaptysBio, Aralez, Arcutis, Arena, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant. Drs Ladha, Rankin, Adly, Stevenson, and Luca have no conflicts of interest to disclose.

Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis., Objective: To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis., Design, Setting, and Participants: Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively., Interventions: Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks., Main Outcomes and Measures: The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points)., Results: Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2., Conclusions and Relevance: Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety., Trial Registration: ClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.

Competing Interests: Conflicts of interest Dr Yeung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Allergan, Amgen, Astellas, Boehringer Ingelheim, Celgene, Centocor, Coherus, Dermira, Eli Lilly, Forward, Galderma, GSK, Janssen, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB, Valeant, and Xenon. Dr Vender has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Centocor, Dermira, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, Takeda, UCB, and Valeant. Dr Devani has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, Tribute, and UCB. Dr Prajapati has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, AnaptysBio, Aralez, Arcutis, Arena, Aspen, Bausch Health, Boehringer Ingelheim, Celgene, Cipher, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Homeocan, Incyte, Janssen, Kymab, LEO Pharma, Medexus, Novartis, Pediapharm, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant. Author Sachdeva and Drs Rankin, Mufti, Luca, Miettunen, and Stevenson have no conflicts of interest to declare.

A novel topical corticosteroid, halobetasol propionate (HP) 0.01% lotion (Bryhali™), has recently been introduced for the treatment of plaque psoriasis and corticosteroid-responsive dermatoses in adults. Once daily application of HP 0.01% lotion is indicated for use up to 8 weeks. Treatment success for plaque psoriasis in the pivotal phase 3 clinical trials (defined as an Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] with ≥2-grade improvement from baseline) occurred in over one-third of patients by week 8. Treatment-emergent adverse events were typically mild-to-moderate in intensity and usually limited to the application site(s). No treatment-related cases of skin atrophy have been reported from the studies. Counselling should be considered to optimize treatment outcomes., Competing Interests: Abrahim Abduelmula and Brian D. Rankin have no relevant disclosures. Ronald Vender has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, Astellas, Celgene, Dermira, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, and Takeda. Jensen Yeung has been an advisor, consultant, speaker, and/or investigator for AbbVie, Allergan, Amgen, Astellas, Boehringer Ingelheim, Celgene, Centocor, Coherus, Dermira, Eli Lilly, Forward, Galderma, GSK, Janssen, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB, Valeant, and Xenon. Alim R. Devani has been an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, AnaptysBio, Arcutis, Arena, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant. Vimal H. Prajapati has been an advisor, consultant, speaker, and/or investigator for AbbVie, Actelion, Amgen, AnaptysBio, Aralez, Arcutis, Arena, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Concert, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Homeocan, Incyte, Janssen, LEO Pharma, Medexus, Nimbus Lakshmi, Novartis, Pediapharm, Pfizer, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant. Funding sources: None.