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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
Information provided by:
Mekos Laboratories AS Identifier:
First received: April 4, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
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 Intervention Phase
Allergic Contact Dermatitis Towards Quaternium-15 Drug: T.R.U.E.Test Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Mekos Laboratories AS:

Estimated Enrollment: 10
Study Start Date: April 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00311454

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

Amtssygehuset i Gentofte Not yet recruiting
Gentofte, Denmark, 2900
Principal Investigator: Torkil Menné         
Sponsors and Collaborators
Mekos Laboratories AS
  More Information Identifier: NCT00311454     History of Changes
Other Study ID Numbers: Mekos 05 UseQ 001
Study First Received: April 4, 2006
Last Updated: April 4, 2006

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases processed this record on August 17, 2017