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NCT Number: NCT07338305

Methotrexat to Hand Eczema in the BIOSKIN Cohort

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Contact Dermatitis Dermatitis Dermatitis, Atopic Dermatitis, Contact Genetic Diseases, Inborn Hand Eczema Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology and Allergy

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Drug survival and side effects

    Time frame: From baseline to at least 5 years

    Treatment duration, side effects and reasons for discontinuation.

Sponsors and collaborators

Lead sponsor

Lone Skov

Other

Collaborators

  • Herlev and Gentofte Hospital
  • University of Copenhagen

Registry information

Official study title

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

Acronym: BIOSKIN: MTX

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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