Evidence map›Paper›PMID 40186746›Full record

ArticleDermatology and therapy2025

Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream.

Timo Buhl, Andrea Bauer, Benjamin D Ehst, Jacob P Thyssen, Julie Hahn-Pedersen, Berith Fredsted Hagen, Eydna D Apol, Tove Agner

Registry-linked trialAbstract read
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03683719 (A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema), 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.

NCT03683719 phase2completednot on this map

A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema

TypeinterventionalSponsorLEO PharmaRan2018 to 2020Enrolled258ConditionsChronic Hand EczemaArmsDelgocitinib cream, Delgocitinib cream vehicle
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

8 authors.

Timo BuhlDepartment of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany. timo.buhl@med.uni-goettingen.de.ORCID http://orcid.org/0000-0002-3139-129X
Andrea BauerDepartment of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
Benjamin D EhstOregon Medical Research Center, Portland, OR, USA.
Jacob P ThyssenDepartment of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Julie Hahn-PedersenLEO Pharma A/S, Ballerup, Denmark.
Berith Fredsted HagenLEO Pharma A/S, Ballerup, Denmark.
Eydna D ApolLEO Pharma A/S, Ballerup, Denmark.
Tove AgnerDepartment of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic Hand Eczema (CHE) is a multifactorial, burdensome, inflammatory skin disease, with limited treatment options. In a double-blind dose-ranging phase 2b clinical trial, participants with CHE received delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, or cream vehicle (clinical results published elsewhere). The objectives were to analyse patient-reported outcomes (PROs) in participants with mild and moderate to severe CHE at screening, and to investigate the impact on PROs during treatment in participants with moderate to severe CHE.

methodsFirstly, Dermatology Life Quality Index (DLQI), EQ-5D-5L, and Hand Eczema Impact Scale (HEIS) per severity were analysed at screening. Secondly, PROs were analysed in the subset of participants with moderate to severe CHE; participants receiving delgocitinib cream 20 mg/g were compared with participants receiving cream vehicle for 16 weeks.

resultsAt screening, mean (SD) DLQI, EQ-5D-5L, and HEIS were 8.1 (5.8), 0.788 (0.175), and 1.7 (0.8), respectively for mild CHE (n = 93), and 12.1 (6.9), 0.689 (0.236), and 2.3 (0.9) for participants with moderate to severe CHE (n = 202), respectively. Among the participants with moderate to severe CHE who received delgocitinib (n = 41), the least squares mean [SE] change from baseline to week 16 improved compared to cream vehicle (n = 38) in DLQI (- 7.1 [0.9] vs. - 4.6 [0.9]), EQ-5D-5L (0.228 [0.032] vs. 0.096 [0.034]), and HEIS (- 1.5 [0.2] vs. - 0.8 [0.2]) (P < 0.05).

conclusionsMild CHE had a moderate effect, whereas moderate to severe CHE had a very large effect on patients' Health-Related Quality of Life at screening. Treatment with delgocitinib cream was associated with considerable improvement in PROs and represents a potentially valuable treatment option.

trial registrationClinicalTrials. gov identifier NCT03683719.

Indexed as

Burden of diseaseChronic Hand EczemaContact dermatitisDelgocitinib creamHealth-related quality of lifePatient-reported outcomes

Identifiers

PMID40186746
PMCPMC12033156

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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.