Evidence map›Paper›PMID 41175336›Full record

Trial reportAmerican journal of clinical dermatology2026

Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks.

Andrew F Alexis, Michael Bukhalo, Fran E Cook-Bolden, James Q Del Rosso, Zoe D Draelos, Janet C DuBois, Laura K Ferris, Seth B Forman, Steven E Kempers, Leon H Kircik and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04445987 (A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04445987 phase2completednot on this map

A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis

TypeinterventionalSponsorArcutis Biotherapeutics, Inc.Ran2020 to 2022Enrolled408ConditionsSeborrheic DermatitisArmsARQ-154
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Andrew F AlexisWeill Cornell Medicine, Dermatology, 211 East 80th St, 2nd Floor, New York, NY, 10075, USA. alexisa@med.cornell.edu.ORCID http://orcid.org/0000-0002-1351-9165
Michael BukhaloArlington Dermatology, Rolling Meadows, IL, USA.
Fran E Cook-BoldenPark South Medical, Bronx, NY, USA.
James Q Del RossoJDR Dermatology Research Center, LLC, Las Vegas, NV, USA.
Zoe D DraelosDermatology Consulting Services, High Point, NC, USA.ORCID http://orcid.org/0000-0001-9803-7415
Janet C DuBoisDermResearch, Inc., Austin, TX, USA.ORCID http://orcid.org/0000-0002-7487-7716
Laura K FerrisDepartment of Dermatology, University of North Carolina, Chapel Hill, NC, USA.
Seth B FormanForCare Medical Center, Tampa, FL, USA.
Steven E KempersMinnesota Clinical Study Center, Fridley, MN, USA.
Leon H KircikWaldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Edward LainSanova Dermatology, Austin, TX, USA.ORCID http://orcid.org/0000-0002-3805-9441
Angela Y MooreArlington Research Center, Arlington, TX, USA.
David M PariserEastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, USA.
Joseph RaoofEncino Research Center, Encino, CA, USA.
Matthew J ZirwasDermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH, USA.ORCID http://orcid.org/0000-0002-8380-8114
Melissa S SealArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Saori KatoArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
David H ChuArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
David KrupaArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Scott SnyderArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Patrick BurnettArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.ORCID http://orcid.org/0009-0000-2103-7185
David R BerkArcutis Biotherapeutics, Inc., Westlake Village, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).

objectivesTo evaluate long-term effects of roflumilast foam 0.3% in patients with SD.

methodsA phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52 weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed.

resultsOverall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear.

conclusionsRoflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks. CLINICALTRIALS: GOV LISTING: NCT04445987.

Indexed as

AminopyridinesBenzamidesDermatitis, SeborrheicPhosphodiesterase 4 InhibitorsAdministration, CutaneousAdolescentAdultAgedCyclopropanesDrug Administration ScheduleFemaleHumansMaleMiddle AgedSeverity of Illness IndexTime FactorsAminopyridinesBenzamidesCyclopropanesPhosphodiesterase 4 InhibitorsRoflumilast

Identifiers

PMID41175336
PMCPMC12860757

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.