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

NCT ID: NCT00133341

Last Updated: 2006-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-12-31

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.

Conditions

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Allergic Contact Dermatitis

Keywords

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Allergic contact dermatitis,patch testing, dilution series

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Goldnatriomthiosulphate, MDBGN, parthenolide

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mekos Laboratories AS

INDUSTRY

Sponsor Role lead

Principal Investigators

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Klaus E Andersen, Prof.

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Odense University Hospital

Odense, Odense C, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MEKOS 05 P379/1

Identifier Type: -

Identifier Source: org_study_id