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This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 foam | Experimental | Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g |
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| Vehicle foam | Placebo Comparator | Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner. Foam vehicle does not contain active ingredients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 foam | Drug | Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin irritation | Skin irritation measured as skin irritation index (summation of clinical scores [ranging from no reaction to blisters] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments | Up to Day 4 |
| Photo irritation | Positive ratios calculated from the photo irritation scores | Up to Day 4 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Co. LTA HAKATA clinic | Fukuoka | Japan |
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| Vehicle of LEO 90100 foam | Drug | Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back |
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