NCT00132600

Clinical Evaluation of Bacitracin

Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Mekos Laboratories AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Contact Dermatitis

Interventions

Type	Name	Description
DRUG	bacitracin (allergen)

Timeline

• Start date: 2005-04-01
• Completion: 2005-07-01
• First posted: 2005-08-22
• Last updated: 2005-10-19

Locations

1 site across 1 country: United States