Clinical Trial: Clinical Evaluation of Bacitracin
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study
Brief Summary: The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.
Detailed Summary:
Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. 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. T.R.U.E. 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 T.R.U.E.Test 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.
Sponsor: Mekos Laboratories AS
Current Primary Outcome: Skin reaction to the patch test after 72-96 hours and after 7 days
Original Primary Outcome: Skin reaction to the patch test after 72-96 hours and after 7 days.
Current Secondary Outcome:
- Evaluation of safety including late and persistent responses
- Evaluation day 3/4, day 7 and day 21
Original Secondary Outcome: Evaluation of safety including late and persistent responses. Evaluation day 3/4, day 7 and day 21.
Information By: Mekos Laboratories AS
Dates:
Date Received: August 19, 2005
Date Started: April 2005
Date Completion: July 2005
Last Updated: October 18, 2005
Last Verified: August 2005
