Status:
COMPLETED
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
Lead Sponsor:
Mekos Laboratories AS
Conditions:
Allergic Contact Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00133341
Start Date
April 1 2005
End Date
December 1 2005
Last Update
February 27 2006
Active Locations (1)
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1
Odense University Hospital
Odense, Odense C, Denmark, 5000