Prospective, Non-interventional, Multicenter Real-world Evidence Study on Effectiveness and Safety of Treatment of Patients With Moderate to Severe Chronic Hand Eczema With Delgocitinib Cream (20mg/g)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- LEO Pharma
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
The goal of this non-interventional study is to assess changes in the signs and symptoms of Chronic Hand Eczema (CHE), as well as the safety profile and use of delgocitinib cream in routine clinical practice, over a 52-week observation period.
The main question it aims to answer is:
Does delgocitinib cream show effectiveness in routine clinical practice in adult patients with moderate to severe Chronic Hand Eczema (CHE), as measured by achievement of a modified Physician Global Assessment (mPGA) score of 0 or 1?
The decision to prescribe delgocitinib cream is made by the treating physician, as part of the participant's routine medical care for CHE.
详细描述
Expected countries to participate includes, but not limited, to Germany, US, Canada, UK, Italy and Spain
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
- 否
入选标准
- •Written informed consent to participate in this study and for collecting and analysing medical data pertinent to the study objectives.
- •Age ≥18 years
- •Patients diagnosed with CHE who are eligible for treatment with delgocitinib cream as per the physician's clinical discretion.
排除标准
- •Currently enrolled in an interventional clinical trial, or have participated in an interventional clinical trial in the past year from the date of enrolment
- •Previous enrolment in this non-interventional study.
- •Previous treatment with delgocitinib cream.