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Quaternium-15, Use Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311454
Recruitment Status : Unknown
Verified April 2006 by Mekos Laboratories AS.
Recruitment status was:  Not yet recruiting
First Posted : April 6, 2006
Last Update Posted : April 6, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Towards Quaternium-15 Drug: T.R.U.E.Test Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : April 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311454

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Contact: Torkil Menné, Prof. +4539773200
Contact: Jacob Thyssen, Ph.D +4539773200

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Amtssygehuset i Gentofte Not yet recruiting
Gentofte, Denmark, 2900
Principal Investigator: Torkil Menné         
Sponsors and Collaborators
Mekos Laboratories AS

Layout table for additonal information Identifier: NCT00311454     History of Changes
Other Study ID Numbers: Mekos 05 UseQ 001
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: April 6, 2006
Last Verified: April 2006
Additional relevant MeSH terms:
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Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases