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Clinical Trial
. 2023 Jun 1;159(6):613-620.
doi: 10.1001/jamadermatol.2023.0846.

Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial

Matthew J Zirwas  1   2   3 , Zoe D Draelos  4 , Janet DuBois  5 , Leon H Kircik  6   7   8   9 , Angela Y Moore  10   11 , Linda Stein Gold  12 , Javier Alonso-Llamazares  13 , Michael Bukhalo  14 , Suzanne Bruce  15 , Kimmie Eads  16 , Lawrence J Green  17 , Scott T Guenthner  18   16 , Laura K Ferris  19 , Seth B Forman  20 , Steven E Kempers  21 , Edward Lain  22 , Charles W Lynde  23   24   25 , David M Pariser  26   27 , Darryl P Toth  28   29 , Paul S Yamauchi  30   31 , Robert C Higham  32 , David Krupa  32 , Patrick Burnett  32 , David R Berk  32
Affiliations
Clinical Trial

Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial

Matthew J Zirwas et al. JAMA Dermatol. .

Abstract

Importance: Current topical treatment options for seborrheic dermatitis are limited by efficacy and/or safety.

Objective: To assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and/or trunk.

Design, setting, and participants: This multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged ≥18 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and/or intertriginous areas. Data analysis was performed from September to October 2020.

Interventions: Once-daily roflumilast foam, 0.3% (n = 154), or vehicle foam (n = 72) for 8 weeks.

Main outcomes and measures: The main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed.

Results: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (P < .001). Roflumilast-treated patients had statistically significantly higher rates of IGA success vs vehicle at week 2, the first time point assessed. Mean (SD) reductions (improvements) on the WI-NRS at week 8 were 59.3% (52.5%) vs 36.6% (42.2%) in the roflumilast and vehicle groups, respectively (P < .001). Roflumilast was well tolerated, with the rate of adverse events similar to that of the vehicle foam.

Conclusions and relevance: The results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment.

Trial registration: ClinicalTrials.gov Identifier: NCT04091646.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Zirwas reported being a consultant and investigator for Arcutis Biotherapeutics (no payment for this work in particular, but was an investigator in this trial) during the conduct of the study; grants from Amgen and UCB; and personal fees from AbbVie, Dermavant, EPI Health, Galderma, Genentech/Novartis, Incyte, L’Oréal, Lilly, Pfizer, Regeneron, and Sanofi outside the submitted work. Dr Draelos reported grants from Arcutis Biotherapeutics during the conduct of the study and outside the submitted work. Dr DuBois reported grants from Arcutis Biotherapeutics during the conduct of the study; grants from AbbVie, AiViva, Allergan, Almirall, AnaptysBio, Bausch Health, Biofrontera, Bristol Myers Squibb (BMS), Caliway Biopharmaceuticals Co, Cara Therapeutics, Croma-Pharma GmbH Austria, Dermata Therapeutics, DermBiont, Dr Reddy, Endo Pharmaceuticals, Evommune, Galderma USA, Leo Laboratories (LEO Pharma), Merck, Palvella Therapeutics, RAPT Therapeutics, and Therapeutics Inc outside the submitted work. Dr Moore reported grants from Arcutis Biotherapeutics outside the submitted work. Dr Stein Gold reported grants and personal fees from Arcutis Biotherapeutics during the conduct of the study; grants from Dermavant, AbbVie, and Lilly; and personal fees from Dermavant, LEO Pharma, Ortho, Pfizer, outside the submitted work. Dr Alonso-Llamazares reported having participated as a principal investigator in the clinical trials of Arcutis Biotherapeutics related to roflumilast on this work and others and serving on the speakers bureau of Arcutis Biotherapeutics on roflumilast. Dr Bukhalo reported grants from Arcutis Biotherapeutics during the conduct of the study; and grants from Johnson & Johnson, Alumis, AbbVie, Eli Lilly, Ventyx, and Galderma outside the submitted work. Dr Bruce reported grants from Arcutis Biotherapeutics during the conduct of the study; grants from Mindera, AbbVie, Dr Reddy, Ortho Dermatologics, Biofrontera, Alumis, Janssen, Timber, Castle, Pfizer, Incyte, Eli Lilly, Concert, AnaptysBio, Galderma, Amgen, Dermira; and personal fees from AbbVie outside the submitted work. Ms Eads reported grants from Arcutis Biotherapeutics (clinical trial fees as a study investigator) during the conduct of the study. Dr Green reported grants from Arcutis Biotherapeutics, personal fees from Arcutis Biotherapeutics (adviser and speaker), grants from Dermavant, personal fees from Dermavant (adviser and speaker), grants from EPI, personal fees from EPI (adviser), and personal fees from Orthoderm (adviser) outside the submitted work. Dr Guenthner reported grants from Arcutis Biotherapeutics (clinical trial fees as a study investigator) during the conduct of the study; and speaking and consulting fees from Arcutis Biotherapeutics outside the submitted work. Dr Ferris reported grants from Arcutis Biotherapeutics during the conduct of the study; grants from BMS, Amgen, Janssen, Dermavant, UCB, Eli Lilly, AbbVie, and Nimbus; personal fees from Arcutis Biotherapeutics, BMS, Janssen, Dermavant, Sun Pharma, and AbbVie outside the submitted work. Dr Lain reported personal fees from BMS, Dermavant, Arcutis Biotherapeutics, Eli Lilly, Pfizer, Incyte, Ortho Dermatologics, Galderma, AbbVie, and EPI Health outside the submitted work. Dr Lynde reported honoraria from Arcutis Biotherapeutics (consulting, principal investigator, advisory board) during the conduct of the study; honoraria (advisory board, consulting, speaking, principal investigator) from AbbVie, Amgen, Arcutis Biotherapeutics, Bausch Health, BMS, Celgene, Dermavant, Eli Lilly, Galderma, Incyte, Innovaderm, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sanofi, Sandoz, Sun Pharma, UCB, and Viatris; and other (principal investigator) from Fresenius Kabi and Kyowa Kirin outside the submitted work. Dr Pariser reported grants from Arcutis Biotherapeutics during the conduct of the study. Dr Yamauchi reported grants from Arcutis Biotherapeutics during the conduct of the study; and grants from Amgen, AbbVie, Lilly, Janssen, LEO Pharma, Pfizer, Regeneron, Sanofi, Dermavant, EPI Health, Novartis, Incyte, and Sun Pharma outside the submitted work. Mr Higham reported personal fees from Arcutis Biotherapeutics (employee and shareholder) during the conduct of the study and outside the submitted work. Mr Krupa reported personal fees from Arcutis Biotherapeutics (employee) during the conduct of the study. Dr Burnett reported other from Arcutis Biotherapeutics (employee) during the conduct of the study. Dr Berk reported personal fees from Arcutis Biotherapeutics (employee, with various compensation including salary, equity, options, and bonus; shareholder) during the conduct of the study; in addition, Dr Berk had a patent for publication No. 20220211730 issued and a patent for publication No. 20220175743 issued. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Flow Diagram
mITT indicates modified intention-to-treat.
Figure 2.
Figure 2.. Percentage of Patients Achieving IGA Successa
aInvestigator Global Assessment (IGA) success = clear or almost clear (on a scale of 0 [completely clear] to 4 [severe]). Error bars indicate 95% CIs.
Figure 3.
Figure 3.. Percentage of Patients Achieving WI-NRS Success Among Patients With Baseline WI-NRS Score of 4 or Greatera
aWorst Itch Numeric Rating Scale (WI-NRS) success = 4-point improvement from baseline WI-NRS score. Error bars indicate 95% CIs.
See this image and copyright information in PMC

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