Clinical Evaluation of Bacitracin

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132600

Enrollment

Registered

2005-08-22

Start date

2005-04-30

Completion date

2005-07-31

Last updated

2005-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Contact Dermatitis

Keywords

Allergic contact dermatitis, Patch testing, bacitracin

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.

Interventions

DRUGbacitracin (allergen)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Skin reaction to the patch test after 72-96 hours and after 7 days	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026