Clinical Evaluation of Bacitracin

Allergic Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132600
• Other study ID #: Mekos 05 P36/2
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2005
• Last updated: October 18, 2005
• Start date: April 2005
• Est. completion date: July 2005

Study information

• Verified date: August 2005
• Source: Mekos Laboratories AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Drug:
• bacitracin (allergen)

Locations

Country	Name	City	State
United States	Dermatological Clinic (Joseph Fowler MD)	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Mekos Laboratories AS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin reaction to the patch test after 72-96 hours and after 7 days
Secondary	Evaluation of safety including late and persistent responses
Secondary	Evaluation day 3/4, day 7 and day 21