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The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 39652 cream | Experimental | Active drug |
|
| LEO 39652 cream vehicle | Placebo Comparator | Placebo drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 39652 cream | Drug |
| ||
| cream vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments | Up to 48 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| LEO 39652 and metabolites in blood | Up to 48 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Chiesa, MD | Covance Clinical Research Unit, Hyde Street, Leeds, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Hyde Street, Leeds, UK | Leeds | LS2 9LH | United Kingdom | |||
| Covance Royal Liverpool Clinical Research Unit |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| Liverpool |
| L7 8XP |
| United Kingdom |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |