Back to resultsQuaternium-15, Use Test
Primary Purpose
Allergic Contact Dermatitis Towards Quaternium-15
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
T.R.U.E.Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Contact Dermatitis Towards Quaternium-15
Eligibility 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
Sites / Locations
- Amtssygehuset i Gentofte
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311454
Brief Title
Quaternium-15, Use Test
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mekos Laboratories AS
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis Towards Quaternium-15
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
T.R.U.E.Test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Torkil Menné, Prof.
Phone
+4539773200
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Thyssen, Ph.D
Phone
+4539773200
Facility Information:
Facility Name
Amtssygehuset i Gentofte
City
Gentofte
ZIP/Postal Code
2900
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torkil Menné
12. IPD Sharing Statement
Learn more about this trial
Quaternium-15, Use Test
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