Clinical Evaluation of Bacitracin

Mekos Laboratories

Status and phase

Completed

Phase 2

Conditions

Allergic Contact Dermatitis

Treatments

Drug: bacitracin (allergen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00132600

Mekos 05 P36/2

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.