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Clinical Evaluation of Bacitracin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00132600
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : October 19, 2005
Sponsor:
Information provided by:
Mekos Laboratories AS

Study Description
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Brief Summary:
The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Drug: bacitracin (allergen) Phase 2

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.

Study Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Skin reaction to the patch test after 72-96 hours and after 7 days

Secondary Outcome Measures :
  1. Evaluation of safety including late and persistent responses
  2. Evaluation day 3/4, day 7 and day 21

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


Locations
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United States, Kentucky
Dermatological Clinic (Joseph Fowler MD)
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Mekos Laboratories AS
Investigators
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Principal Investigator: Joseph Fowler, Prof. Mekos Laboratories AS
More Information
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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
Keywords provided by Mekos Laboratories AS:
Allergic contact dermatitis
Patch testing
bacitracin
Additional relevant MeSH terms:
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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