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

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

Sponsors

Lead Sponsor: Mekos Laboratories AS

Source Mekos Laboratories AS
Brief Summary

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

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.

Overall Status Completed
Start Date 2005-04-01
Completion Date 2005-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
Secondary Outcome
Measure Time Frame
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Goldnatriomthiosulphate, MDBGN, parthenolide

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Klaus E Andersen, Prof. Principal Investigator Odense University Hospital
Location
Facility: Odense University Hospital
Location Countries

Denmark

Verification Date

2006-02-01

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: Double

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