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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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT00311454

Locations
Denmark
Amtssygehuset i Gentofte
Gentofte, Denmark, 2900
Sponsors and Collaborators
Mekos Laboratories AS
  More Information

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016