Atopic Dermatitis, Contact Dermatitis, Hand Eczema
Conditions
Keywords
Skin immunology, Real-life
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.
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.
Interventions
None listed
Sponsors
University of Copenhagen
Herlev and Gentofte Hospital
Lone Skov
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome: Dermatology Life Quality Index (DLQI) | Baseline to at least 5 years | A validated patient-reported questionnaire measuring the impact of skin disease on quality of life. |
| Clinical characteristics | 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. |
| Allergic and genetic characteristics | At least 5 years | Filaggrin mutation status, and positive patch/skin prick tests; and total serum IgE level from blood samples. |
| Drug survival and side effects | From baseline to at least 5 years | Treatment duration, side effects and reasons for discontinuation. |
Countries
Denmark
Outcome results
None listed