Clinical Evaluation of Bacitracin
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ClinicalTrials.gov Identifier: NCT00132600 |
Recruitment Status :
Completed
First Posted : August 22, 2005
Last Update Posted : October 19, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Contact Dermatitis | Drug: bacitracin (allergen) | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Diagnostic |
Official Title: | Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study |
Study Start Date : | April 2005 |
Study Completion Date : | July 2005 |

- Skin reaction to the patch test after 72-96 hours and after 7 days
- Evaluation of safety including late and persistent responses
- Evaluation day 3/4, day 7 and day 21

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132600
United States, Kentucky | |
Dermatological Clinic (Joseph Fowler MD) | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Joseph Fowler, Prof. | Mekos Laboratories AS |
ClinicalTrials.gov Identifier: | NCT00132600 |
Other Study ID Numbers: |
Mekos 05 P36/2 |
First Posted: | August 22, 2005 Key Record Dates |
Last Update Posted: | October 19, 2005 |
Last Verified: | August 2005 |
Allergic contact dermatitis Patch testing bacitracin |
Dermatitis Dermatitis, Contact Dermatitis, Allergic Contact Skin Diseases Skin Diseases, Eczematous Hypersensitivity, Delayed |
Hypersensitivity Immune System Diseases Bacitracin Anti-Infective Agents, Local Anti-Infective Agents Anti-Bacterial Agents |