Clinical Evaluation of Bacitracin - Full Text View

Sponsored by:	Mekos Laboratories AS
Information provided by:	Mekos Laboratories AS
ClinicalTrials.gov Identifier:	NCT00132600

Purpose

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

Condition	Intervention	Phase
Allergic Contact Dermatitis	Drug: bacitracin (allergen)	Phase II

Drug Information available for: Bacitracin Bacitracin zinc

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study

Further study details as provided by Mekos Laboratories AS:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Evaluation of safety including late and persistent responses
Evaluation day 3/4, day 7 and day 21

Estimated Enrollment:	20
Study Start Date:	April 2005
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132600

Locations

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

Sponsors and Collaborators

Mekos Laboratories AS

Investigators

Principal Investigator:

Joseph Fowler, Prof.

Mekos Laboratories AS

More Information

Study ID Numbers:	Mekos 05 P36/2
Study First Received:	August 19, 2005
Last Updated:	October 18, 2005
ClinicalTrials.gov Identifier:	NCT00132600
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mekos Laboratories AS:

Allergic contact dermatitis
Patch testing
bacitracin

Study placed in the following topic categories:

Hypersensitivity
Hypersensitivity, Delayed
Skin Diseases
Dermatitis, Allergic Contact

Skin Diseases, Eczematous
Bacitracin
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local

Immune System Diseases
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009