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It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.
The TRUE Test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. TRUE test panel 1 and 2 contain 23 of the most frequent contact allergens.With these 23 allergens, 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 TRUE Test in order to detect more contact allergic reactions. Therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third TRUE Test panel. This study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. A phase-III study will be performed afterwards to establish the efficacy and safety of the three allergens.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goldnatriomthiosulphate, MDBGN, parthenolide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade) |
| Measure | Description | Time Frame |
|---|---|---|
| Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus E Andersen, Prof. | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Odense C | 5000 | Denmark |
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| Label | URL |
|---|---|
| Sponsor's homepage | View source |
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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 |
|---|---|
| C039411 | 1,2-dibromo-2,4-dicyanobutane |
| C002669 | parthenolide |
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| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |