Polymyxin B, Bacitracin, and Neomycin Ophthalmic Ointment |
AK-Spore Ophthalmic Ointment; Neocidin Ophthalmic Ointment; Neosporin Ophthalmic Ointment; Ocutricin Ophthalmic Ointment |
Clinical Trial: Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study.
This study has been completed.
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Allergic Contact Dermatitis | Drug: bacitracin (allergen) | Phase II |
MedlinePlus related topics: Allergy; Dermatitis
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Secondary Outcomes: Evaluation of safety including late and persistent responses. Evaluation day 3/4, day 7 and day 21.
Expected Total Enrollment: 20
Study start: April 2005; Study completion: September 2005
Last follow-up: July 2005; Data entry closure: August 2005
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
Inclusion Criteria:
- Positive Bacitracin patch test within the latest 5 years.
- Age more 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.
4. Treatment with UV-light during the latest 3 weeks. 5. Widespread active dermatitis or dermatitis on test area. 6. Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study.
7. Subjects not able to cooperate.
Location Information
Kentucky
Dermatological clinic (Joseph Fowler MD), Louisville, Kentucky, 40202, United States
Joseph Fowler, Prof., Principal Investigator, unaffiliated
More Information
Last Updated: August 19, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00132600
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- AK-Spore Ophthalmic Ointment (Drug Digest)
- Neocidin Ophthalmic Ointment (Drug Digest)

Not Signed In -

