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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311454

Enrollment

Registered

2006-04-06

Start date

2006-04-30

Completion date

Unknown

Last updated

2006-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Contact Dermatitis Towards Quaternium-15

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.

Interventions

DRUGT.R.U.E.Test

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Denmark

Contacts

Primary ContactTorkil Menné, Prof.

+4539773200

Backup ContactJacob Thyssen, Ph.D