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Clinical Evaluation of Bacitracin

Information source: Mekos Laboratories AS
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Contact Dermatitis

Intervention: bacitracin (allergen) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Mekos Laboratories AS

Official(s) and/or principal investigator(s):
Joseph Fowler, Prof., Principal Investigator, Affiliation: Mekos Laboratories AS


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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Primary outcome: Skin reaction to the patch test after 72-96 hours and after 7 days

Secondary outcome:

Evaluation of safety including late and persistent responses

Evaluation day 3/4, day 7 and day 21

Detailed description: Thin-layer Rapid Use Epicutaneous Test (T. R.U. E. TestŪ) 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

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

Starting date: April 2005
Last updated: October 18, 2005

Page last updated: August 20, 2015

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