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Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

2014-08-27 03:32:00 | BioPortfolio

Summary

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").

Description

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.

Study Design

Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Contact Dermatitis

Intervention

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Location

Dermatology Specialists PSC
Louisville
Kentucky
United States
40202-1864

Status

Completed

Source

Allerderm

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:00-0400

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