Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132600
Status:
COMPLETED
Last Update Posted:
2005-10-19
First Post:
2005-08-19
Brief Title:
Clinical Evaluation of Bacitracin
Sponsor:
Mekos Laboratories AS
Organization:
Mekos Laboratories AS
Study Overview
Official Title:
Clinical Evaluation of Bacitracin A Phase II Dose-Response Study
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis
Detailed Description:
Thin-layer Rapid Use Epicutaneous Test TRUE Test is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis
The 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 TestTM panels 1 and 2 contain 23 of the most frequent contact allergens With the 23 allergens the test currently consists of 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 TRUETest in order to detect more contact allergic reactions Bacitracin is one of these allergens and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series
The 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 TestTM panels 1 and 2 contain 23 of the most frequent contact allergens With the 23 allergens the test currently consists of 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 TRUETest in order to detect more contact allergic reactions Bacitracin is one of these allergens and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series
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