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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000519-15 | EudraCT Number |
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The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 32731 cream | Experimental | Topical application |
|
| LEO 32731 cream vehicle | Placebo Comparator | Topical application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 32731 cream | Drug | Applied for 3 weeks |
| |
| LEO 32731 cream vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Total sign score at end of treatment on entire treatment area | Total sign score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores (erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness) for each area | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total sign score on limited treatment area on entire treatment area during trial | 3 week | |
| Investigator's treatment area assessment of disease severity on entire treatment area during trial | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proinnovera GmbH, Center of Dermatology Excellence | Münster | 48159 | Germany |
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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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| Drug |
Applied for 3 weeks |
|
| Subject's treatment area assessment of disease severity on entire treatment area during trial | 3 weeks |
| Subject's assessment of itching on entire treatment area during trial | 3 weeks |
| Transepidermal water loss during trial | 3 weeks |
| Individual signs score on entire treatment during trial | 3 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |