Quaternium-15, Use Test

Phase 4

• Conditions: Allergic Contact Dermatitis Towards Quaternium-15

• Registration Number: NCT00311454
• Lead Sponsor: Mekos Laboratories AS

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 Description

Not available

Study Timeline

• Status Verified: 2006-04
• Study Start: 2006-04
• Study First Submitted: 2006-04-04
• Study First Submitted QC: 2006-04-04
• Last Update Submitted: 2006-04-04
• Study First Posted: 2006-04-06
• Last Update Posted: 2006-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Amtssygehuset i Gentofte; 🇩🇰 Gentofte, Denmark