Bacitracin (allergen) in Allergic Contact Dermatitis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Allergic Contact Dermatitis

Intervention / Treatment

Drug: bacitracin (allergen)

Detailed Description

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.

Study Type

Interventional

Enrollment

20

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Dermatological Clinic (Joseph Fowler MD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Skin reaction to the patch test after 72-96 hours and after 7 days

Secondary Outcome Measures

Outcome Measure
Evaluation of safety including late and persistent responses
Evaluation day 3/4, day 7 and day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mekos Laboratories AS

Investigators

Principal Investigator: Joseph Fowler, Prof., Mekos Laboratories AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria