NCT00311454

Quaternium-15, Use Test

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: Mekos Laboratories AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Contact Dermatitis Towards Quaternium-15

Interventions

Type	Name	Description
DRUG	T.R.U.E.Test

Timeline

• Start date: 2006-04-01
• First posted: 2006-04-06
• Last updated: 2006-04-06

Locations

1 site across 1 country: Denmark