Methotrexat to Hand Eczema in the BIOSKIN Cohort

NCT07338305 | Active Not Recruiting

• 3 other identifiers: H-21032986LFST21500002No grant number
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis; Contact Dermatitis; Hand Eczema

Keywords

Skin immunology; Real-life

Outcome Measures

Primary Outcomes (1)

• Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI)

  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 Outcomes (4)

• Patient Reported Outcome: Dermatology Life Quality Index (DLQI)

  Baseline to at least 5 years

• Clinical characteristics

  Baseline to at least 5 years

• Allergic and genetic characteristics

  At least 5 years

• Drug survival and side effects

  From baseline to at least 5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Department of Dermatology and Allergy, Herlev and Gentofte Hospital,

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lone Skov: lead
• University of Copenhagen: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Department of Dermatology and Allergy

Hellerup, 2900, Denmark

Location

Related Publications (1)

• Lovendorf MB, Johansen JD, Skov L. BIOSKIN: A Protocol for the Copenhagen Translational Skin Immunology Biobank and Research Programme. BMJ Open. 2024 Feb 24;14(2):e077207. doi: 10.1136/bmjopen-2023-077207.

  PMID: 38401898 BACKGROUND

Related Links

• Website for participants, researchers and patients

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis, Contact

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lone Skov, Professor

  Department of Dermatology and Allergy, Herlev and Gentofte Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 13, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)