Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2005-04-30
2005-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
DOUBLE
Interventions
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bacitracin (allergen)
Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years.
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mekos Laboratories AS
INDUSTRY
Principal Investigators
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Joseph Fowler, Prof.
Role: PRINCIPAL_INVESTIGATOR
Mekos Laboratories AS
Locations
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Dermatological Clinic (Joseph Fowler MD)
Louisville, Kentucky, United States
Countries
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Other Identifiers
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Mekos 05 P36/2
Identifier Type: -
Identifier Source: org_study_id