Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Hand Eczema (CHE). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Detailed description
Expected countries to participate includes, but not limited, to Germany, US, Canada, UK, Italy and Spain
Primary outcome measures
- modified Physician Global Assessment (mPGA) [Time frame: The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).]
Secondary outcome measures (2)
- Safety and tolerability of delgocitinib cream treatment [Time frame: The safety and tolerability of delgocititinib will be assessed at baseline, at each study visit during the study (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).]
- Short-term and long-term effectiveness of treatment with delgocitinib cream [Time frame: The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- LEO Pharma — Neu-Isenburg
Identifiers
NCT: NCT07603193 · NIS-Delgo-2448