Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:04 AM
Study NCT ID:
NCT07338305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methotrexat to Hand Eczema in the BIOSKIN Cohort
Sponsor:
Lone Skov
Organization:
Study Overview
Official Title:
The Copenhagen Translational Skin Immunology Biobank and Research Program - BIOSKIN: Methotrexat to Hand Eczema
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOSKIN: MTX
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: