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Louisville, Kentucky 40202


Purpose:

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 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").


Study summary:

Primary endpoint: To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include: - Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects. - Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration. - Concordance/discordance as compared to the corresponding reference petrolatum allergen. Secondary endpoint: To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include: - The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning. - The frequency and characterization of adverse events and serious adverse events. - The frequency and characterization of late and/or persistent reactions.


Criteria:

Inclusion Criteria: - Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix. - All subjects must be adults (18 years of age or older) and otherwise in good health. - Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion. - Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations. Exclusion Criteria: - Subjects unable to meet inclusion requirements. - Women who are breastfeeding or pregnant. - Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. - Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents. - Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks. - Acute dermatitis outbreak or dermatitis on or near the test area on the back. - Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). - Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.


NCT ID:

NCT00640250


Primary Contact:

Principal Investigator
Evy Paulsen, M.D., Ph.D
Odense University Hospital


Backup Contact:

N/A


Location Contact:

Louisville, Kentucky 40202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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