Quaternium-15, Use Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Contact Dermatitis Towards Quaternium-15

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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T.R.U.E.Test

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Amtssygehuset i Gentofte

Gentofte Municipality, Gentofte, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Torkil Menné, Prof.

Role: CONTACT

+4539773200

Jacob Thyssen, Ph.D