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Completed

NCT Number: NCT00132600

Clinical Evaluation of Bacitracin

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

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Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatological Clinic (Joseph Fowler MD)

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bacitracin (allergen)

Drug

Primary outcomes

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

Secondary outcomes

  1. Evaluation of safety including late and persistent responses

  2. Evaluation day 3/4, day 7 and day 21

Sponsors and collaborators

Lead sponsor

Mekos Laboratories AS

Industry

Registry information

Official study title

Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study

Important dates

Study start
2005
Study completion
2005
First posted
Aug 22, 2005
Registry last updated
Oct 19, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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