Methotrexat to Hand Eczema in the BIOSKIN Cohort (BIOSKIN: MTX)

January 5, 2026 updated by: Lone Skov

The Copenhagen Translational Skin Immunology Biobank and Research Program - BIOSKIN: Methotrexat to Hand Eczema

Handeczema is a common chronic skin disease that markedly affect health and quality of life. Effective treatment is limited by the lack of biomarkers that can predict disease course, comorbidities and treatment response. This study is is an observational, prospective, study of patients initiating treatment with methotrexat at the Department of Dermatology and Allergy at Herlev- and Gentofte Hospital.

The main aim is to study the clinical effect of methotrexat in patients with hand eczema. Secondary aims are to study drug survival, reasons for termination of treatment and side effects.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The Copenhagen Translational Skin Immunology Biobank and Research Programme (BIOSKIN) is a prospective translational biobank and research study designed to recruit 3,000 patients with atopic dermatitis, allergic contact dermatitis or psoriasis over at least five years. The open longitudinal study design allows participants to enter and leave the cohort at time points that reflect their natural disease and treatment course. At each study visit, investigators collect biological samples, conduct structured interviews, and obtain patient-reported outcomes on disease-specific and general health-related factors.

In this study of patients initiating treatment with methotrexat because of hand eczema, patients are assessed with clinical assessments including dermatologist-verified diagnose, evaluation of disease severity, and detailed phenotyping. Examinations are performed before and after initiation of methotrexat as a tablet or as subcutaneous injections, and at least annually.

Longitudinal modelling will enable detailed characterisation of the patiens and disease trajectories and treatment responses. The aim is to improve understanding of the effect and sideeffects of methotrexat in a cohort of hand eczema patients with moderate to severe disease.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Department of Dermatology and Allergy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Department of Dermatology and Allergy, Herlev and Gentofte Hospital,

Description

Inclusion Criteria:

  • Individuals of any age with psoriasis, atopic dermatitis, contact dermatitis, or other inflammatory skin diseases.
  • Patients seen at the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, or recruited through public advertisement.
  • Ability to provide informed consent (parent/guardian for minors).
  • Healthy volunteers

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent.
  • Any condition that, in the investigator's judgment, makes participation inappropriate or unsafe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with chronic hand eczema
Patients diagnosed with chronic hand eczema and initiating treatment with systemic methotrexat enrolled for longitudinal clinical biological follow-up in a real-life setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI)
Time Frame: baseline to at least 5 years
A validated clinical scoring system used to assess the severity and extent of hand eczema based on clinical signs and area involved, will be used
baseline to at least 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome: Dermatology Life Quality Index (DLQI)
Time Frame: Baseline to at least 5 years
A validated patient-reported questionnaire measuring the impact of skin disease on quality of life.
Baseline to at least 5 years
Clinical characteristics
Time Frame: Baseline to at least 5 years
Baseline characteristics of included patients for example if they are current smokers, if they have wet work, previous systemic treatments, registred etiology and morphology and duration of hand eczema and disease activity.
Baseline to at least 5 years
Allergic and genetic characteristics
Time Frame: At least 5 years
Filaggrin mutation status, and positive patch/skin prick tests; and total serum IgE level from blood samples.
At least 5 years
Drug survival and side effects
Time Frame: From baseline to at least 5 years
Treatment duration, side effects and reasons for discontinuation.
From baseline to at least 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lone Skov

Collaborators

University of Copenhagen
Herlev and Gentofte Hospital

Investigators

  • Study Director: Lone Skov, Professor, Department of Dermatology and Allergy, Herlev and Gentofte Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21032986
  • No grant number (Other Grant/Funding Number: The Swedish Society of Spinal Surgeons)
  • LFST21500002 (Other Grant/Funding Number: The LEO fundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to restrictions under the Danish Data Protection Act and related regulations, which do not permit the disclosure of identifiable or potentially identifiable health data to external parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe