Allergic Contact Dermatitis Towards Quaternium-15 Clinical Trial
Official title:
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
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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Amtssygehuset i Gentofte | Gentofte |
| Lead Sponsor | Collaborator |
|---|---|
| Mekos Laboratories AS |
Denmark,