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| ID | Type | Description | Link |
|---|---|---|---|
| 1401842 | Other Identifier | Company Internal |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Topical application of verum (azelaic acid pre foam formulation) on the skin |
|
| Vehicle | Placebo Comparator | Topical application of vehicle formulation (same as verum but without active drug substance) on the skin |
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| Negative control | Placebo Comparator | Topical application of distilled water (negative control) on the skin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azelaic acid pre foam formulation | Drug |
| ||
| Vehicle pre foam formulation |
| Measure | Description | Time Frame |
|---|---|---|
| skin sensitization reaction | skin reactions will be assessed, using a standardized scoring scale | day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase) |
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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 |
|---|---|---|---|---|---|---|
| Robert I. Cooper, MD | Fargo | North Dakota | 58104 | United States |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Drug |
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| Water | Drug |
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| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |