Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133341
Status:
COMPLETED
Last Update Posted:
2006-02-27
First Post:
2005-08-22
Brief Title:
Clinical Evaluation of the 3 Allergens Methyldibromoglutharonitrile Parthenolide and Goldnatriumthiosulphate
Sponsor:
Mekos Laboratories AS
Organization:
Mekos Laboratories AS
Study Overview
Official Title:
Clinical Evaluation of the 3 Allergens Methyldibromoglutharonitrile Parthenolide and Goldnatriumthiosulphate for TRUE Test Panel 3 - a Phase II Dose-Response Study
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 allergensWith 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None