Clinical Trial: Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
Brief Summary: To evaluate the diagnostic performance (primary) and safety (secondary) of seven T.R.U.E. Test Panel 3.2 allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol in pediatric subjects 6-18 years of age with suspected contact dermatitis based on symptoms and clinical history.
Detailed Summary:
The study population will include at least 100 consecutive subjects 6-17 years of age with suspected contact dermatitis based on symptoms and clinical history. Study subjects must be otherwise healthy and fulfill entry criteria.
Visit 1 (Day 0): Informed Consent, Inclusion/Exclusion Criteria Assessment, Medical and Medicine History, Pregnancy Test (for female subjects of child-bearing potential), Panel Placement.Visit 2 (Day 2): Panel Removal, Panel Adhesion and Irritation Assessment, AE and Concomitant Medication Review.Visit 3 (Day 3- approximately 72 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 4 (Day 4 approximately 96 hours after placement): Skin Reactions Assessed and Scored. Adverse Event and Concomitant Medication Review.Visit 5 (Day 7±1): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit 6 (Day 21±2): Skin Reaction Assessed and Scored. AE and Concomitant Medication Review. Visit performed via phone call, unless investigator determines that subject should be seen in clinic.
Primary Endpoint: Frequency and characterization of positive reactions per allergen. Secondary Endpoint: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events.
Sponsor: Allerderm
Current Primary Outcome: Change in Frequency and characterization of positive reactions per allergen. [ Time Frame: 72 hours, 96 hours, 1 week, 21 Days ]
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: 72 hours, 96 hours, 1 week, 21 days ]
Original Secondary Outcome: Same as current
Information By: Allerderm
Dates:
Date Received: March 16, 2011
Date Started: December 2012
Date Completion: December 2013
Last Updated: February 26, 2013
Last Verified: February 2013
