Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for TRUE Test® Panel 3 - a Phase II, Dose-Response Study.

Conditions
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Allergic Contact Dermatitis

Intervention / Treatment
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* Drug: Goldnatriomthiosulphate, MDBGN, parthenolide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years. Age more or equal to 18 years. Signed informed consent. Exclusion Criteria: Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area. Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days. Treatment with UV-light during the latest 3 weeks. Widespread active dermatitis or dermatitis on test area. Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period. Subjects not able to cooperate. Participation in other clinical studies during the study period and 3 weeks prior to study start.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Goldnatriomthiosulphate, MDBGN, parthenolide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC]) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic contact dermatitis,patch testing, dilution series