Evidence map›Paper›PMID 40862624›Full record

Trial reportPediatric dermatology2025

Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years.

Adelaide A Hebert, Shireen V Guide, Vlada Groysman, Mercedes E Gonzalez, Daisy Blanco, Vivian Laquer, Melissa S Seal, Archie Thurston, David Krupa, Scott Snyder and 4 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Pediatric dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04655313 phase2completednot on this map

An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 6 to 11 Years Old) With Plaque Psoriasis

TypeinterventionalSponsorArcutis Biotherapeutics, Inc.Ran2020 to 2022Enrolled20ConditionsPsoriasis, Plaque PsoriasisArmsARQ-151 cream 0.3%
NCT04746911 phase2completednot on this map

An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 2 to 5 Years Old) With Plaque Psoriasis

TypeinterventionalSponsorArcutis Biotherapeutics, Inc.Ran2021 to 2022Enrolled10ConditionsPsoriasis, Plaque PsoriasisArmsARQ-151 cream 0.3%
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

14 authors.

Adelaide A HebertUTHealth McGovern Medical School, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-9167-5729
Shireen V GuideChildren's Hospital of Orange County, Orange, California, USA.
Vlada GroysmanCahaba Dermatology & Skin Health Center, Birmingham, Alabama, USA.
Mercedes E GonzalezPediatric Skin Research, LLC, Miami, Florida, USA.
Daisy BlancoInstituto Dermatologico, Santa Domingo, Dominican Republic.
Vivian LaquerFirst OC Dermatology Research, Fountain Valley, California, USA.
Melissa S SealArcutis Biotherapeutics Inc., Westlake Village, California, USA.
Archie ThurstonArcutis Biotherapeutics Inc., Westlake Village, California, USA.
David KrupaArcutis Biotherapeutics Inc., Westlake Village, California, USA.
Scott SnyderArcutis Biotherapeutics Inc., Westlake Village, California, USA.
Patrick BurnettArcutis Biotherapeutics Inc., Westlake Village, California, USA.
David H ChuArcutis Biotherapeutics Inc., Westlake Village, California, USA.
David R BerkArcutis Biotherapeutics Inc., Westlake Village, California, USA.
Robert C HighamArcutis Biotherapeutics Inc., Westlake Village, California, USA.

Funding

Arcutis Biotherapeutics Inc.
6 · The paper itself

Abstract

Two 4-week, phase 2, open-label, maximal usage pharmacokinetic (PK) and safety studies of once-daily roflumilast cream 0.3% (a potent phosphodiesterase 4 inhibitor) were conducted in children aged 2-5 years and 6-11 years with psoriasis. Evidence of systemic exposure to roflumilast and its active N-oxide metabolite was seen in most patients following daily application, consistent with previous studies. Under maximal use conditions, once-daily roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis in children aged 2-11 years, consistent with phase 3 results in adults and adolescents. Trial Registration: Clinicaltrials.gov listing: 215: NCT04655313; 216: NCT04746911.

Indexed as

AminopyridinesBenzamidesPhosphodiesterase 4 InhibitorsPsoriasisChildChild, PreschoolCyclopropanesDrug Administration ScheduleFemaleHumansMaleSeverity of Illness IndexSkin CreamTreatment OutcomeAminopyridinesBenzamidesCyclopropanesPhosphodiesterase 4 InhibitorsRoflumilastchildrenpharmacokineticspsoriasisroflumilast cream 0.3%topical treatment

Identifiers

PMID40862624
PMCPMC12854914

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.