Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Contact Dermatitis Clinical Trial

Official title: Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol

Status Completed

Clinical Trial Summary

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, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

Clinical Trial Description

Primary endpoint:

The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on:

• Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens.

• Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:

• The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period.

• The frequency of adverse events and serious adverse events. ;

Related Conditions & MeSH terms

• Contact Dermatitis
• Dermatitis
• Dermatitis, Contact

• NCT number: NCT00640614
• Study type: Interventional
• Source: Allerderm
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Completion date: October 2009