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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D003877', 'term': 'Dermatitis, Contact'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI)', 'timeFrame': 'baseline to at least 5 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome: Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline to at least 5 years', 'description': 'A validated patient-reported questionnaire measuring the impact of skin disease on quality of life.'}, {'measure': 'Clinical characteristics', 'timeFrame': 'Baseline to at least 5 years', 'description': '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.'}, {'measure': 'Allergic and genetic characteristics', 'timeFrame': 'At least 5 years', 'description': 'Filaggrin mutation status, and positive patch/skin prick tests; and total serum IgE level from blood samples.'}, {'measure': 'Drug survival and side effects', 'timeFrame': 'From baseline to at least 5 years', 'description': 'Treatment duration, side effects and reasons for discontinuation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin immunology', 'Real-life'], 'conditions': ['Atopic Dermatitis', 'Contact Dermatitis', 'Hand Eczema']}, 'referencesModule': {'references': [{'pmid': '38401898', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.bioskin.dk/', 'label': 'Website for participants, researchers and patients'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nIn 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.\n\nLongitudinal 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Department of Dermatology and Allergy, Herlev and Gentofte Hospital,', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals of any age with psoriasis, atopic dermatitis, contact dermatitis, or other inflammatory skin diseases.\n* Patients seen at the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, or recruited through public advertisement.\n* Ability to provide informed consent (parent/guardian for minors).\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent.\n* Any condition that, in the investigator's judgment, makes participation inappropriate or unsafe."}, 'identificationModule': {'nctId': 'NCT07338305', 'acronym': 'BIOSKIN: MTX', 'briefTitle': 'Methotrexat to Hand Eczema in the BIOSKIN Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'The Copenhagen Translational Skin Immunology Biobank and Research Program - BIOSKIN: Methotrexat to Hand Eczema', 'orgStudyIdInfo': {'id': 'H-21032986'}, 'secondaryIdInfos': [{'id': 'LFST21500002', 'type': 'OTHER_GRANT', 'domain': 'The LEO fundation'}, {'id': 'No grant number', 'type': 'OTHER_GRANT', 'domain': 'The Copenhagen University Hospital, Herlev and Gentofte Hospital, Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chronic hand eczema', 'description': 'Patients diagnosed with chronic hand eczema and initiating treatment with systemic methotrexat enrolled for longitudinal clinical biological follow-up in a real-life setting.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Department of Dermatology and Allergy', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Lone Skov, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Dermatology and Allergy, Herlev and Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lone Skov', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD.', 'investigatorFullName': 'Lone Skov', 'investigatorAffiliation': 'Copenhagen University Hospital at Herlev'}}}}