Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
- Conditions
- Allergic Contact Dermatitis
- Registration Number
- NCT00133341
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
- Secondary Outcome Measures
Name Time Method Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
Trial Locations
- Locations (1)
Odense University Hospital
🇩🇰Odense, Odense C, Denmark