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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008138-36 | EudraCT Number | ||
| Sinecort | Other Identifier | Company Internal |
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The study is focused to prove a favorable safety profile of the new formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexpanthenol (Sinecort, BAY81-2996) | Drug | 1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Irritation rate | After 21 applications |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation potential | After 21 applications |
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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 |
|---|---|---|---|---|---|---|
| Münster | North Rhine-Westphalia | 48155 | Germany |
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| ID | Term |
|---|---|
| C007288 | dexpanthenol |
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| Positive control, Na-laurylsulfat-solution | Drug | 50 mikro liter of 0.5 % Sodium-laurylsulfate-solution |
|
| Untreated skin under application chamber | Device | Application of treatment chamber as in arm 1 and arm 2 on untreated skin |
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