Clinical Trial: Quaternium-15, Use Test

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: An Open Single Centre Evaluation of the Reactivity of the T.R.U.E. Test Quaternium-15 Patch and a Real Use Exposure in Subjects Known to Be Allergic to Quaternium-15

Brief Summary: The study is required by the FDA as part of a post-marketing commitment. The purpose of the study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use exposure.The subjects will wear the patch test for 48 hours and reading will be performed day 3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions from respectively TRUE Test and use test will be compared using the McNemar Change Test.

Detailed Summary:
Sponsor: Mekos Laboratories AS

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mekos Laboratories AS

Dates:
Date Received: April 4, 2006
Date Started: April 2006
Date Completion:
Last Updated: April 4, 2006
Last Verified: April 2006