Clinical Evaluation of Bacitracin
Summary
The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.
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
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Conditions
Allergic Contact Dermatitis
Intervention
bacitracin (allergen)
Location
Dermatological Clinic (Joseph Fowler MD)
Louisville
Kentucky
United States
40202
Status
Completed
Source
Mekos Laboratories AS
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00132600
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Dermatitis, Allergic Contact
A contact dermatitis due to allergic sensitization to various substances. These substances subsequently produce inflammatory reactions in the skin of those who have acquired hypersensitivity to them as a result of prior exposure.
Dermatitis, Contact
A type of acute or chronic skin reaction in which sensitivity is manifested by reactivity to materials or substances coming in contact with the skin. It may involve allergic or non-allergic mechanisms.
Dermatitis, Irritant
A non-allergic contact dermatitis caused by prolonged exposure to irritants and not explained by delayed hypersensitivity mechanisms.
Dermatitis, Toxicodendron
An allergic contact dermatitis caused by exposure to plants of the genus Toxicodendron (formerly Rhus). These include poison ivy, poison oak, and poison sumac, all plants that contain the substance urushiol, a potent skin sensitizing agent. (From Dorland, 27th ed)
Tulipa
A plant genus of the family LILIACEAE. Members contain tuliposides and tulipalins and have been associated with allergic contact dermatitis in florists.
Clinical Trials
The current knowledge of the pathophysiology of allergic contact dermatitis is based on the murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the re...
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortison...
A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to Moderat...
The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the treatment of skin allergic reaction to nickel. The study drug and placebo will be administered...
Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4...
PubMed Articles
We report a case of a 39-year-old woman from Adelaide who developed allergic contact dermatitis to the rare allergen indium in her ring. The allergen was sourced for patch testing using the Contact Al...
Current Strategies in Treating Severe Contact Dermatitis in Pediatric Patients.
Allergic contact dermatitis in children is underdiagnosed and undertreated, and its incidence is increasing. Appropriate history taking and the suspicion for allergic contact dermatitis is essential,...
Diagnosis and management of contact dermatitis.
Contact dermatitis is a common inflammatory skin condition characterized by erythematous and pruritic skin lesions that occur after contact with a foreign substance. There are two forms of contact der...
Pin site allergic contact dermatitis: an unusual complication of halo fixation.
We report a case of halo pin site allergic contact dermatitis, a rare complication of halo vest immobilisation (HVI), necessitating device removal. Although uncommon, pin site allergic contact dermati...
Allergic contact dermatitis is one of the most common occupational diseases. A main protective mechanism in those who do not develop allergic contact dermatitis is tolerance induction by repeated exp...
