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

Mekos Laboratories AS60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Allergic Contact Dermatitis

Interventions

Goldnatriomthiosulphate, MDBGN, parthenolideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Odense University Hospital

Odense, Odense C, Denmark

Outcomes

Primary Outcomes

Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)

Secondary Outcomes

Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

Data from ClinicalTrials.gov

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