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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003090-22 | EudraCT Number |
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Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.
This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany.
The trial consists of a screening phase, an induction phase, a rest phase, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | topical occlusive administration |
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| Delgocitinib cream vehicle | Placebo Comparator | topical occlusive administration |
|
| Untreated skin | No Intervention | topical occlusive administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib cream | Drug | Cream for topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive skin reaction at 72 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 evaluation of skin reaction at the end of the challenge phase performed using the following scale:
| Up to 72 hours after irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events from baseline to 14 days after subject's end of trial | Treatment-emergent adverse event | From baseline to 14 days after subject's end of trial (Day 5 of challenge phase, or if applicable Day 5 of re-challenge phase. |
| Skin reaction score after irradiation during induction phase |
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Key Inclusion Criteria:
Exclusion Criteria:
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| 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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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 Day 22 |
| Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6). | 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 Day 40 |