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Quaternium-15, Use Test

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2006 by Mekos Laboratories AS.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Mekos Laboratories AS
ClinicalTrials.gov Identifier:
NCT00311454
First received: April 4, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted

April 4, 2006
April 4, 2006
April 2006
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No Changes Posted
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Quaternium-15, Use Test
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Allergic Contact Dermatitis Towards Quaternium-15
Drug: T.R.U.E.Test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
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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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00311454
Mekos 05 UseQ 001
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Mekos Laboratories AS
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Mekos Laboratories AS
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP