Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311454
Status:
UNKNOWN
Last Update Posted:
2006-04-06
First Post:
2006-04-04
Brief Title:
Quaternium-15 Use Test
Sponsor:
Mekos Laboratories AS
Organization:
Mekos Laboratories AS
Study Overview
Official Title:
An Open Single Centre Evaluation of the Reactivity of the TRUE Test Quaternium-15 Patch and a Real Use Exposure in Subjects Known to Be Allergic to Quaternium-15
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
NOT_YET_RECRUITING
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 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 exposureThe 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 Description:
None
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