Contact Dermatitis Clinical Trial
Official title:
Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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