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

Sponsor

Mekos Laboratories AS (Industry)

Overall Status

Completed

CT.gov ID

NCT00133341

Collaborator

(none)

Enrollment

Location

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Contact Dermatitis	Drug: Goldnatriomthiosulphate, MDBGN, parthenolide	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Apr 1, 2005

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.