Evidence map›Paper›PMID 40525591›Full record

ArticleJournal of the European Academy of Dermatology and Venereology : JEADV2025

Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema.

Diamant Thaçi, Melinda Gooderham, Paola Lovato, Daniel Elenius Madsen, Anders Soehoel, Robert Bissonnette

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

Article in Journal of the European Academy of Dermatology and Venereology : JEADV, 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT05050279 early_phase1completednot on this map

A Phase 1 Clinical Trial to Evaluate QTcF Prolongation and Proarrhythmic Potential of the Non Antiarrhythmic Drug Delgocitinib Following Oral Administration in Healthy Subjects

TypeinterventionalSponsorLEO PharmaRan2021 to 2022Enrolled40ConditionsHealthyArmsDelgocitinib capsule, Placebo capsule
NCT05486117 phase1completednot on this map

A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Twice-daily Applications of Delgocitinib Cream 20 mg/g for 1 Week in Adult Subjects With Moderate to Severe Chronic Hand Eczema.

TypeinterventionalSponsorLEO PharmaRan2022 to 2022Enrolled15ConditionsChronic Hand EczemaArmsDelgocitinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Reply to 'Delayed absorption and systemic variability of topical delgocitinib in Chronic Hand Eczema'.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  5. Review
  6. Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Article
  7. 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

6 authors.

Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Melinda GooderhamDepartment of Dermatology, Queens University, Peterborough, Ontario, Canada.ORCID https://orcid.org/0000-0001-8926-0113
Paola LovatoLEO Pharma A/S, Ballerup, Denmark.
Daniel Elenius MadsenLEO Pharma A/S, Ballerup, Denmark.
Anders SoehoelLEO Pharma A/S, Ballerup, Denmark.
Robert BissonnetteInnovaderm Research, Montreal, Quebec, Canada.ORCID https://orcid.org/0000-0001-5927-6587

Funding

LEO Pharma A/S, Ballerup, Denmark
6 · The paper itself

Abstract

backgroundChronic Hand Eczema (CHE) is a prevalent inflammatory skin condition characterized by pain, pruritus and significant impact on patients' quality of life. Delgocitinib cream, a pan-Janus kinase inhibitor, has shown potential in targeting the key mediators of CHE. To develop a detailed trial drug safety profile, it is vital to assess systemic exposure and bioavailability following repeated drug applications.

objectivesThis analysis aimed to evaluate the systemic exposure and bioavailability of delgocitinib cream 20 mg/g in adults with moderate to severe CHE and compare these parameters with those from oral delgocitinib administration in healthy adults.

methodsAn open-label, single-arm, Phase 1 trial (NCT05486117) was conducted involving 16 adults with moderate to severe CHE. Participants applied delgocitinib cream 20 mg/g twice daily for 1 week. Pharmacokinetic sampling was performed on Day (D)1 and D8. Systemic exposure was compared with data from two Phase 1 trials involving oral delgocitinib in healthy adults (1.5-12 mg, NCT05050279, and 1-100 mg, NBX1-1).

resultsDelgocitinib cream demonstrated minimal systemic exposure, with geometric mean maximum plasma concentration (C

conclusionsDelgocitinib cream shows minimal systemic exposure and is well tolerated in patients with moderate to severe CHE. These findings suggest that no systemic pharmacological effect is expected with the application of delgocitinib cream 20 mg/g to the hands and wrists of patients with moderate to severe CHE. CLINICALTRIALS: gov (or equivalent) listing: NCT05486117, NCT05050279.

Indexed as

EczemaHand DermatosesAdultAgedBiological AvailabilityChronic DiseaseFemaleHumansMaleMiddle AgedPyrrolesSeverity of Illness IndexSkin CreamYoung AdultdelgocitinibPyrroles

Identifiers

PMID40525591
PMCPMC12376242

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.