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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000849-80 | EudraCT Number |
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The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 39652 cream | Experimental | Topical application |
|
| LEO 39652 cream vehicle | Placebo Comparator | Topical application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 39652 cream | Drug | Applied for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sign score at end of treatment | 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 assessed area. | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total sign score on limited treatment area | 22 days | |
| Investigator's treatment area assessment of disease severity | 22 days | |
| Subject´s treatment area assessment of disease severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia Graßhoff, MD | Proinnovera GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proinnovera GmbH, Center of Dermatology Excellence | Münster | 48159 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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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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| 22 days |
| Subject´s assessment of itching | 22 days |
| Transepidermal Water Loss | 22 days |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |