Quaternium-15, Use Test

This study is not yet open for participant recruitment.

Verified by Mekos Laboratories AS, April 2006

First Received: April 4, 2006 No Changes Posted

Sponsored by:	Mekos Laboratories AS
Information provided by:	Mekos Laboratories AS
ClinicalTrials.gov Identifier:	NCT00311454

Purpose

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311454

Contacts

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

Locations

Denmark
Amtssygehuset i Gentofte
Gentofte, Denmark, 2900

Sponsors and Collaborators

Mekos Laboratories AS

More Information

No publications provided

Study ID Numbers:	Mekos 05 UseQ 001
Study First Received:	April 4, 2006
Last Updated:	April 4, 2006
ClinicalTrials.gov Identifier:	NCT00311454 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Hypersensitivity
Hypersensitivity, Delayed
Skin Diseases
Dermatitis, Allergic Contact

Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Hypersensitivity
Hypersensitivity, Delayed
Immune System Diseases
Skin Diseases

Dermatitis, Allergic Contact
Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009