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| ID | Type | Description | Link |
|---|---|---|---|
| 1401841 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.
This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.
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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 |
|
| Negative control | Placebo Comparator | Topical application of distilled water (negative control) on the skin |
|
| Positive control | Active Comparator | Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azelaic acid pre-foam formulation | Drug |
| ||
| Vehicle pre-foam formulation |
| Measure | Description | Time Frame |
|---|---|---|
| irritancy rating scale | skin reaction as well as superficial layer effects will be scored according to standardized scales | 21 days |
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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 |
| D012967 | Sodium Dodecyl Sulfate |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Drug |
|
| Water | Drug |
|
| Sodium lauryl sulfate | Drug |
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |