Atopic DermatitisBIOSKIN: MTXNCT07338305
Methotrexat to Hand Eczema in the BIOSKIN Cohort
An observational study of Atopic Dermatitis and Contact Dermatitis, run by Lone Skov at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Contact Dermatitis, Hand Eczema
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Department of Dermatology and Allergy, Herlev and Gentofte Hospital,
Who may be able to join
- 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
Who cannot join
- Inability or unwillingness to provide informed consent.
- Any condition that, in the investigator's judgment, makes participation inappropriate or unsafe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Copenhagen Translational Skin Immunology Biobank and Research Program - BIOSKIN: Methotrexat to Hand Eczema
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Contact Dermatitis, Hand Eczema
- Keywords
- Skin immunology, Real-life
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to at least 5 years
Secondary outcomes (4)
Patient Reported Outcome: Dermatology Life Quality Index (DLQI)
A validated patient-reported questionnaire measuring the impact of skin disease on quality of life.
Measured: 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.
Measured: 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.
Measured: At least 5 years
Drug survival and side effects
Treatment duration, side effects and reasons for discontinuation.
Measured: From baseline to at least 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lone Skov
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Herlev and Gentofte Hospital
- Responsible party
- Sponsor-investigator, Lone Skov, Copenhagen University Hospital at Herlev
- Investigators
- Lone Skov, Professor, Study director, Department of Dermatology and Allergy, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338305
- Sponsor's protocol ID
- H-21032986
- Other IDs
- LFST21500002, No grant number
- Acronym
- BIOSKIN: MTX
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 38401898
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Copenhagen Translational Skin Immunology Biobank and Research Program - BIOSKIN: Methotrexat to Hand Eczema
- ClinicalTrials.gov ID
- NCT07338305
- Acronym / sponsor ID
- BIOSKIN: MTX / H-21032986
- Conditions
- Atopic Dermatitis, Contact Dermatitis, Hand Eczema
- Keywords
- Skin immunology, Real-life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lone SkovUniversity, hospital or other
- Collaborators
- University of Copenhagen, Herlev and Gentofte Hospital
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Dermatology and Allergy, Herlev and Gentofte Hospital,
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability or unwillingness to provide informed consent.
- Any condition that, in the investigator's judgment, makes participation inappropriate or unsafe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI)
Time frame: 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
4 secondary outcomes
Patient Reported Outcome: Dermatology Life Quality Index (DLQI)
Time frame: Baseline to at least 5 years
Clinical characteristics
Time frame: Baseline to at least 5 years
Allergic and genetic characteristics
Time frame: At least 5 years
Drug survival and side effects
Time frame: From baseline to at least 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 38401898Lovendorf 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.
- Website for participants, researchers and patientsLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Skov, Professor study director
Department of Dermatology and Allergy, Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Contact Dermatitis, run by Lone Skov at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI) (time frame: baseline to at least 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.