We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Concordance
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Bacitracin
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Parthenolide
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Disperse Blue
Timeframe: Visit 5: 21 days after patch application
Diagnostic Performance: Sensitivity and Specificity: Bronopol
Timeframe: Visit 5: 21 days after patch application