Quaternium-15, Use Test

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mekos Laboratories AS

Criteria

Inclusion Criteria:

• Sensitivity to quaternium-15

• Age more than 18 years

Exclusion Criteria:

• Topical or systemic treatment with corticosteroids or immunosuppresives.

• Treatment with UV-light

• Widespread active dermatitis or dermatitis on test area