NCT00640250

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

Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Allerderm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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").

Detailed 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.

Conditions

• Contact Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens	Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-09-01
• First posted: 2008-03-21
• Last updated: 2018-04-09
• Results posted: 2018-04-09

Locations

2 sites across 2 countries: United States, Denmark