Clinical Evaluation of Bacitracin

Phase 2

Completed

• Conditions: Allergic Contact Dermatitis

• Registration Number: NCT00132600
• Lead Sponsor: Mekos Laboratories AS

Brief Summary

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

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 Timeline

• Study Start: 2005-04
• Study Completion: 2005-07
• Status Verified: 2005-08
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Last Update Submitted: 2005-10-18
• Last Update Posted: 2005-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Skin reaction to the patch test after 72-96 hours and after 7 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of safety including late and persistent responses
Evaluation day 3/4, day 7 and day 21

Trial Locations

Locations (1)

Dermatological Clinic (Joseph Fowler MD); 🇺🇸 Louisville, Kentucky, United States