Clinical Evaluation of Bacitracin

NCT ID: NCT00132600

Last Updated: 2005-10-19

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.

Detailed Description

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Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. Test®) is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis.

The standard panel consists of two tape strips, panel 1, with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. T.R.U.E. TestTM panels 1 and 2 contain 23 of the most frequent contact allergens. With the 23 allergens the test currently consists of, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in T.R.U.E.Test in order to detect more contact allergic reactions. Bacitracin is one of these allergens, and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series.

Conditions

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Allergic Contact Dermatitis

Keywords

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Allergic contact dermatitis Patch testing bacitracin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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bacitracin (allergen)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive bacitracin patch test within the latest 5 years.
* Age greater than or equal to 18 years.
* Signed informed consent.

Exclusion Criteria

* Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
* Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
* Treatment with ultraviolet (UV)-light during the latest 3 weeks.
* Widespread active dermatitis or dermatitis on test area.
* Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study.
* Subjects not able to cooperate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mekos Laboratories AS

INDUSTRY

Sponsor Role lead

Principal Investigators

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Joseph Fowler, Prof.

Role: PRINCIPAL_INVESTIGATOR

Mekos Laboratories AS

Locations

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Dermatological Clinic (Joseph Fowler MD)

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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Mekos 05 P36/2

Identifier Type: -

Identifier Source: org_study_id