The Copenhagen Translational Skin Immunology Biobank and Research Program - BIOSKIN: Methotrexat to Hand Eczema
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Inability or unwillingness to provide informed consent.
- •Any condition that, in the investigator's judgment, makes participation inappropriate or unsafe.
研究组 & 干预措施
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.
结局指标
主要结局
Longitudinal Clinical Disease Activity: Hand Eczema Severity Index (HECSI)
时间窗: 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
次要结局
- Patient Reported Outcome: Dermatology Life Quality Index (DLQI)(Baseline to at least 5 years)
- Clinical characteristics(Baseline to at least 5 years)
- Allergic and genetic characteristics(At least 5 years)
- Drug survival and side effects(From baseline to at least 5 years)
研究者
Lone Skov
Professor, MD.
Copenhagen University Hospital at Herlev