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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000705-67 | EudraCT Number |
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This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delgocitinib cream 1 mg/g | Experimental | Single topical occlusive administration |
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| Delgocitinib cream 3 mg/g | Experimental | Single topical occlusive administration |
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| Delgocitinib cream 8 mg/g | Experimental | Single topical occlusive administration |
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| Delgocitinib cream 20 mg/g | Experimental | Single topical occlusive administration |
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| Delgocitinib cream vehicle | Placebo Comparator | Single topical occlusive administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib cream | Drug | Cream for topical application |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive skin reaction at 24 hours or 48 hours after irradiation | A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale:
| Up to 48 hours after irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Positive skin reaction at 24 hours after irradiation | A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale:
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events from baseline to Day 4 | From time of first investigational medicinal product application (Day 1) until Day 4 |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioskin Research Center Dermatology | Hamburg | 20095 | Germany |
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All subjects will receive all treatments with treatments randomised over test fields.
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| Delgocitinib cream vehicle | Drug | The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
|
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| 24 hours after irradiation |
| Positive skin reaction at 48 hours after irradiation | A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale:
| 48 hours after irradiation |