Clinical Trial: Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)

Brief Summary: To evaluate the performance and safety of seven T.R.U.E. Test Panel allergens in subjects 6-17 years of age with suspected contact dermatitis.

Detailed Summary: To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel allergens; Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history.
Sponsor: Allerderm

Current Primary Outcome: Frequency and characterization of positive reactions per allergen. [ Time Frame: Day 21 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events. [ Time Frame: Day 21 ]

Original Secondary Outcome: Same as current

Information By: Allerderm

Dates:
Date Received: February 20, 2013
Date Started: December 2012
Date Completion: December 2015
Last Updated: September 22, 2014
Last Verified: December 2013