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| Name | Class |
|---|---|
| Optimapharm | INDUSTRY |
| ICON Clinical Research | INDUSTRY |
| IQVIA Inc. | INDUSTRY |
| Vivactis M2Research |
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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.
Expected countries to participate includes, but not limited, to Germany, US, Canada, UK, Italy and Spain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with moderate to severe CHE treated with delgocitinib cream as routine clinical care | No interventions |
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| Measure | Description | Time Frame |
|---|---|---|
| modified Physician Global Assessment (mPGA) | The modified physician global assessment (mPGA) scale will be used to assess the CHE severity and progression before and after the topical treatment with delgocitinib. The mPGA scale will be used by the treating physicians to rate the severity of CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of delgocitinib cream treatment | Assess adverse drug reactions and serious adverse events during the conduct of the study. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be selected from hospitals or dermatology clinics (private or public)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma | Neu-Isenburg | Germany |
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| INDUSTRY |
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| Short-term and long-term effectiveness of treatment with delgocitinib cream |
The modified physician global assessment (mPGA) scale will be used to assess the CHE severity and progression before and after the topical treatment with delgocitinib. The mPGA scale will be used by the treating physicians to rate the severity of CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| 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). |