Clinical Trial: Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study
Brief 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 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.
Sponsor: Allerderm
Current Primary Outcome: Determination of optimal test concentration for Disperse Blue 106 and Bronopol as the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects. [ Time Frame: End of Study ]
Original Primary Outcome: Determination of optimal test concentration for Disperse Blue 106 and Bronopal as the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects. [ Time Frame: End of Study ]
Current Secondary Outcome: Frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen and concentration. [ Time Frame: End of study ]
Original Secondary Outcome: Same as current
Information By: Allerderm
Dates:
Date Received: March 3, 2008
Date Started: April 2008
Date Completion:
Last Updated: February 19, 2013
Last Verified: May 2010