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| ID | Type | Description | Link |
|---|---|---|---|
| 1402942 | Other Identifier | Company internal |
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The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zk 245186 0.01% ointment | Active Comparator | Active treatment, lowest dose |
|
| ZK 245186 0.03% ointment | Active Comparator | Active comparator middle dose |
|
| ZK 245186 0.1% ointment | Active Comparator | Active comparator highest dose |
|
| Vehicle ointment | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZK 245186 | Drug | Once daily topical non-occlusive application for up to 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment of target area | up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International (Bloemfontein) | Bloemfontein | 9301 | South Africa | |||
| PAREXEL International (George) |
| 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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| ID | Term |
|---|---|
| C546413 | R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol |
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| Placebo (vehicle ointment) | Drug | Once daily topical non-occlusive application for up to 4 weeks |
|
| George |
| 6529 |
| South Africa |
| PAREXEL International (Port Elizabeth) | Newton Park | 6045 | South Africa |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |