An observational study in Atopic Dermatitis, Contact Dermatitis and Hand Eczema, sponsored by Lone Skov. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Lone Skov · Observational
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 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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Lone Skov is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Department of Dermatology and Allergy, Herlev and Gentofte Hospital,
Exclusion Criteria:
Patients diagnosed with chronic hand eczema and initiating treatment with systemic methotrexat enrolled for longitudinal clinical biological follow-up in a real-life setting.
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
Time frame: baseline to at least 5 years
Patient Reported Outcome: Dermatology Life Quality Index (DLQI)
A validated patient-reported questionnaire measuring the impact of skin disease on quality of life.
Time frame: Baseline to at least 5 years
Clinical characteristics
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.
Time frame: Baseline to at least 5 years
Allergic and genetic characteristics
Filaggrin mutation status, and positive patch/skin prick tests; and total serum IgE level from blood samples.
Time frame: At least 5 years
Drug survival and side effects
Treatment duration, side effects and reasons for discontinuation.
Time frame: From baseline to at least 5 years
Plan to share: No — 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.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lone Skov