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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002569-20 | EudraCT Number |
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The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phoenix II | Experimental | Application over 29 days twice daily |
|
| Phoenix I | Active Comparator | Application over 29 days twice daily |
|
| Untreated skin | No Intervention | Untreated skin areas of subjects will be observed over 29 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phoenix II (BAY81-2996) | Device |
| ||
| Phoenix I (BAY81-2996) |
| Measure | Description | Time Frame |
|---|---|---|
| Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index | Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal vital signs | Vital signs consist of blood pressure, heart rate, and body temperature | Up to 10 weeks |
| Number of patients with adverse events as a measure of safety and tolerability |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Münster | North Rhine-Westphalia | 48155 | 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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|
| Up to 10 weeks |
| Erythema by means of chromametry | Up to 29 days |
| Transepidermal water loss (TEWL) as a measure for skin barrier function | Up to 29 days |
| Skin hydration by means of corneometry | Up to 29 days |
| Intensity of pruritus by means of visual analogue scale (VAS) | Up to 29 days |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |