Quaternium-15, Use Test

Mekos Laboratories

Status and phase: Unknown; Phase 4

Conditions: Allergic Contact Dermatitis Towards Quaternium-15

Treatments: Drug: T.R.U.E.Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311454

Mekos 05 UseQ 001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)