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The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.
Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. Test®) is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis.
The standard panel consists of two tape strips, panel 1, with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. T.R.U.E. TestTM panels 1 and 2 contain 23 of the most frequent contact allergens. With the 23 allergens the test currently consists of, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in T.R.U.E.Test in order to detect more contact allergic reactions. Bacitracin is one of these allergens, and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bacitracin (allergen) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Skin reaction to the patch test after 72-96 hours and after 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety including late and persistent responses | ||
| Evaluation day 3/4, day 7 and day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Fowler, Prof. | Mekos Laboratories AS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatological Clinic (Joseph Fowler MD) | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001414 | Bacitracin |
| D000485 | Allergens |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |