Clinical evaluation of the 3 allergens: Methyldibromoglutharonitrile, Parthenolide and Goldsodiumthiosulphate for TRUE Test Panel 3 - a phase II, dose-response study.
- Conditions
- Diagnosis of Allergic Contact Dermatitis.
- Registration Number
- EUCTR2004-004899-36-DK
- Lead Sponsor
- Mekos Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1.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.
2. Age more than or equal to 18 years.
3. Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
2.Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
4.Treatment with UV-light during the latest 3 weeks.
5.Widespread active dermatitis or dermatitis on test area.
6.Breast-feeding, pregnancy or insufficient contraception.If any doubt a negative urine-pregnancy test should be demonstrated or the test should be postponed.
7.Subjects not able to cooperate.
8.Participation in other clinical studies during the study period and 3 weeks prior to study start.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the optimum concentration of the 3 patches: Methyldibromoglutharonitrile, Parthenolide and Goldsodiumthiosulphate.;Secondary Objective: Safety<br>To evaluate the 2 vehicles PVP and HPC for the Methyldibromoglutharonitrile patch.;Primary end point(s): To establish the optimum dose/concentration of a MDBGN-patch, a Parthenolide-patch and a Goldnatriumthiosulphate-patch for a third TRUE Test® Panel
- Secondary Outcome Measures
Name Time Method