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Clinical Trial
. 2025 Jul 1;161(7):698-706.
doi: 10.1001/jamadermatol.2025.1136.

Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial

Melinda J Gooderham  1   2   3 , Javier Alonso-Llamazares  4 , Jerry Bagel  5 , Neal Bhatia  6 , Michael Bukhalo  7 , Janet DuBois  8 , Laura K Ferris  9 , Lawrence Green  10 , Leon H Kircik  11   12   13   14 , Benjamin Lockshin  15 , Wei Jing Loo  16   17   18 , Kim A Papp  19   20   21 , Jennifer Soung  22 , Melissa S Seal  23 , Scott Snyder  23 , Saori Kato  23 , David Krupa  23 , Patrick Burnett  23 , David R Berk  23 , David H Chu  23
Affiliations
Clinical Trial

Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial

Melinda J Gooderham et al. JAMA Dermatol. .

Abstract

Importance: Current topical treatments for scalp psoriasis are limited by formulation, efficacy, and/or safety.

Objective: To assess safety and efficacy of roflumilast foam, 0.3%, in patients with psoriasis of the scalp and body.

Design, setting, and participants: This was a phase 3 double-blinded, vehicle-controlled randomized clinical trial conducted between August 24, 2021, and June 3, 2022, at 49 sites in Canada and the US. Eligible participants were 12 years and older with plaque psoriasis affecting up to 25% of the scalp and body, at least 10% of the scalp, and up to 20% of nonscalp areas, with a minimum Scalp-Investigator Global Assessment (S-IGA) score of 3 (moderate), and minimum Body-IGA (B-IGA) score of 2 (mild). Data analyses were performed from September 9 to December 30, 2022.

Interventions: Once-daily roflumilast foam, 0.3%, or vehicle for 8 weeks.

Main outcomes and measures: Coprimary end points were S-IGA and B-IGA success (clear [0] or almost clear [1] plus ≥2-grade improvement) at week 8. Secondary end points included S-IGA success at weeks 2 and 4, change in Scalp Itch-Numeric Rating Scale (SI-NRS), and SI-NRS and Worst Itch-NRS (WI-NRS) success (≥4-point improvement in patients with baseline score of ≥4). Safety and tolerability were also assessed.

Results: A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) or vehicle (n = 151). At week 8, 66.4% of the roflumilast group achieved S-IGA success vs 27.8% of the vehicle group (P < .001); and 45.5% of the roflumilast group achieved B-IGA success compared with 20.1% of the vehicle group (P < .001). Rates for S-IGA success at week 2 and SI-NRS and WI-NRS success at weeks 2, 4, and 8 were significantly higher for roflumilast vs vehicle. Improvements in SI-NRS were greater for the roflumilast vs the vehicle group as early as the first assessment (24 hours after the first application). Both study groups had low rates of adverse events and favorable tolerability profiles.

Conclusions and relevance: This randomized clinical trial found that roflumilast foam, 0.3%, improved signs and symptoms of psoriasis on the scalp and body, including pruritus, with low rates of adverse events in patients 12 years and older. These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body.

Trial registration: ClinicalTrials.gov Identifier: NCT05028582.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gooderham reported honoraria, research, and/or speaking fees from AbbVie, Acelyrin, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Bausch Health, Bristol Myers Squibb, Boehringer Ingelheim, Dermira, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Inmagene, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, MoonLake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, and Ventyx, outside the submitted work. Dr Alonso-Llamazares reported research funding from Driven Research during the conduct of the study; and involvement with the speaking bureau of Arcutis, outside the submitted work. Dr Bagel reported personal fees from AbbVie, Bristol Myers Squibb, Janssen, Sun Pharma, and Pfizer outside the submitted work. Dr DuBois reported grants from AbbVie, Amplifica, Biofrontera, Bluefin Biomedicine, Bristol Myers Squibb, Cassiopea, Croma-Pharma, Dermata Therapeutics, and Incyte and consulting fees from Accure Acne, Medytox, Merck, Moberg Pharma, Nail Genesis, Nielsen Biosciences, RAPT Therapeutics, Sanofi, Scarless Labs, Therapeutics Inc, VeraDermics, VYNE Therapeutics, Aclaris Therapeutics, TechnoDerma Medicines, Concerto Biosciences, and Biofrontera, all outside the submitted work. Dr Ferris reported personal fees from Arcutis, Bristol Myers Squibb, AbbVie, Janssen, and Amgen, all outside the submitted work. Dr Green reported advisory, research, and speaking fees from Amgen, Arcutis, Dermavant, Bristol Myers Squibb, Alumis Takeda, Galderma, Jannes, Lilly, OrthoDerm, and UCB, all outside the submitted work. Dr Kircik reported honorarium and/or grants for advisory board, consulting, research, and/or speaking from AbbVie, Allergan, Almirall, Amgen, Arcutis, Biogen-Idec, Bristol Myers Squibb, Boehringer-Ingelheim, Breckinridge Pharma, Celgene, Centocor, Cellceutix, Cipher, COMBINA Trix, Connetics, Coria, Dermavant, Dermira, Dow Pharmaceutical Sciences, Dr Reddy’s Lab, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, PLC, Idera, Johnson & Johnson, Leo, Maruho, Merck, Medicis Pharma, Nimbus, Novartis AG, Promius Pharma, Pharmaderm, Pfizer, Merck Serono, Stiefel, Sun Pharma, Taro, UCB, Valeant Pharma, Ventyx, and XenoPort, all outside the submitted work. Dr Lockshin personal fees from AbbVie, Eli Lilly, Regeneron, Sanofi, Boehringer Ingelheim, Incyte, Leo Pharma, Pfizer, and UCB outside the submitted work. Dr Papp reported personal fees from AbbVie, Acelyrin, Akros, Alumis, Amgen, Arcutis, Bain Capital, Bausch Health/Valeant, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celltrion, Concert Pharmaceuticals, CorEvitas, Dermavant, Dermira, Dice Pharmaceuticals/Therapeutics, Eli Lilly, Evelo Biosciences, Forbion, Galderma, Horizon Therapeutics, Incyte, Janssen, Kenvue, Kymab, Kyowa Hakko Kirin, Leo, Meiji Seika Pharma, Mitsubishi Pharma, Nektar, Nimbus Therapeutics, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, Tarsus Pharmaceuticals, UCB, and Zai Lab, all outside the submitted work. Dr Soung reported nonfinancial support for manuscript preparation from Arcutis during the conduct of the study; personal fees, grants, honoraria, and/or speaking fees from Amgen, Arcutis, Eli Lilly, AbbVie, Pfizer, LEO Pharma, Regeneron, Sanofi, Dermavant, Novartis Bristol Myers Squibb, Johnson & Johnson, UCB KoBio Labs, Coval Biopharma, Boehringer Ingelheim, Novartis Ortho Dermatologics, all outside the submitted work. Dr Snyder reported equity in Arcutis during the conduct of this study. Dr Burnett reported a patent for topical roflumilast. Dr Berk reported equity and patents (issued: 17/542072; pending: 17/703543, 18/627861, 18/789083, 18/335315, 63/662742, 18/827222, 18/884931, 18/884941) during the conduct of this study. Dr Chu equity in Arcutis outside the submitted and a patent pending for roflumilast. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram of Study Participants
Figure 2.
Figure 2.. Proportions of Patients With S-IGA Success and B-IGA Success, by Week
S-IGA success and B-IGA success were defined as score of clear (0) or almost clear (1) plus at least a 2-grade or greater improvement from baseline. Error bars represent 97.5% CIs; boxes indicate timing of coprimary end points of S-IGA and B-IGA success at week 8. B-IGA indicates Body−Investigator Global Assessment; S-IGA, Scalp−Investigator Global Assessment. aNominal P value.
Figure 3.
Figure 3.. Response to Roflumilast Foam, 0.3%, in 2 Participants With Scalp Psoriasis, From Baseline to Week 8
S-IGA indicates Scalp−Investigator Global Assessment, and SI-NRS, Scalp Itch−Numeric Rating Scale.
See this image and copyright information in PMC

References

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