Evidence map›Paper›PMID 42143645›Full record

ArticleDermatology and therapy2026

Minimal Systemic Exposure with Maximal Delgocitinib Cream Use in Patients with Severe Chronic Hand Eczema in the DELTA 2 Randomized, Vehicle-Controlled, Double-Blind, Phase 3 Trial.

Melinda Gooderham, Christopher G Bunick, JiaDe Yu, Douglas Maslin, Shannon K R Schneider, Marie Louise Østerdal, Anders Søhoel, Daniel Elenius Madsen, Lawrence F Eichenfield

2 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2026. 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 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.

NCT03826901 phase1completednot on this map

A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorLEO PharmaRan2019 to 2021Enrolled46ConditionsAtopic DermatitisArmsdelgocitinib
NCT04872101 phase3completednot on this map

A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 2)

TypeinterventionalSponsorLEO PharmaRan2021 to 2023Enrolled473ConditionsChronic Hand EczemaArmsDelgocitinib cream, Cream vehicle
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

9 authors.

Melinda GooderhamSKiN Centre for Dermatology, Probity Medical Research and Queen's University, Peterborough, ON, Canada. mgooderham@centrefordermatology.com.ORCID http://orcid.org/0000-0001-8926-0113
Christopher G BunickDepartment of Dermatology and Program in Translational Biomedicine, Yale University School of Medicine, New Haven, CT, USA.
JiaDe YuDepartment of Dermatology, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.
Douglas MaslinLEO Pharma A/S, Ballerup, Denmark.
Shannon K R SchneiderLEO Pharma Inc., Madison, NJ, USA.
Marie Louise ØsterdalLEO Pharma A/S, Ballerup, Denmark.
Anders SøhoelLEO Pharma A/S, Ballerup, Denmark.
Daniel Elenius MadsenLEO Pharma A/S, Ballerup, Denmark.
Lawrence F EichenfieldDepartments of Dermatology and Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDelgocitinib cream is a topical pan-Janus kinase inhibitor approved for adults with moderate to severe Chronic Hand Eczema (CHE) in the USA, Canada, European Union, and multiple other countries. Here, we assessed the systemic exposure of twice-daily topical application of delgocitinib cream 20 mg/g in adults with moderate to severe CHE treated under normal or maximal use conditions in the DELTA 2 trial and compared with the systemic exposure in adults with moderate to severe atopic dermatitis (AD) from a delgocitinib cream phase 1 AD trial.

methodsBlood sampling was performed 2-6 h after delgocitinib cream application at weeks 1, 4, and 16 in DELTA 2. In the delgocitinib cream phase 1 trial, blood sampling was performed prior to application and at six timepoints (0-12 h) post-application on day 1 and day 8. Geometric mean delgocitinib plasma concentrations were calculated in DELTA 2 and peak delgocitinib plasma concentrations (geometric mean C

resultsIn DELTA 2, patients treated with delgocitinib cream under normal (n = 294; body surface area [BSA], 1.48%; application, 7.3 g/week) or maximal use conditions (n = 19; BSA, 2.17%; application, 13.7 g/week) showed geometric mean delgocitinib plasma concentrations at week 1 of 0.19 ng/mL (n = 268) and 0.58ng/mL, respectively. In the phase 1 trial, patients (n = 14; BSA, 33.6%; application, 72.3 g/week) showed a geometric mean C

conclusionDelgocitinib cream 20 mg/g resulted in minimal systemic exposure among adults with moderate to severe CHE, including those treated under maximal use conditions. Low systemic exposure was also observed in adults with moderate to severe AD, despite substantially greater BSA involvement and higher delgocitinib cream usage, highlighting the properties of delgocitinib cream's novel formulation.

trial registrationNCT03826901 (phase 1, delgocitinib cream); study start date: 20 February 2019; primary completion date: 29 October 2021; study completion date: 29 October 2021. NCT04872101 (DELTA 2); study start date: 25 May 2021; primary completion date: 27 December 2022; study completion date: 6 January 2023.

Indexed as

Atopic dermatitisChronic Hand EczemaDelgocitinib creamDELTA 2Systemic exposure

Identifiers

PMID42143645
PMCPMC13280073

What OpenQuestion holds

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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.