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

Status Completed

Clinical Trial 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").

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00640250
Study type	Interventional
Source	Allerderm
Contact
Status	Completed
Phase	Phase 2
Start date	April 2008
Completion date	September 2009

View Details

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