Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents
An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents. After consent and enrollment, the timeline is as follows:A. T.R.U.E. TEST panels 1.1, 2.1 ,3.1 will be applied to the skin on the subject's back. All patch test panels will remain at the back until removed at the #2 Clinic Visit that occurs 2 days later. B. Skin reactions to all patch test panel allergens will be evaluated and scored shortly after panel removal.C. Skin reactions will be evaluated and scored again at either 3 or 4 days after #1 Clinic Visit. An additional follow-up visit (#3B Clinic Visit) may occur days after day 0 if needed to verify skin reactions.D. Skin reactions will be evaluated and scored again at the #4 Clinic Visit, which will occur 7 days +/- 2 days after #1 Clinic Visit (day 0). E. A follow up visit will take place approximately 3 weeks (21 + 2 days) after #1 Clinic Visit (day 0) to record any late or persistent reactions, and any adverse events. Investigators may elect to perform this evaluation via telephone if no reactions are present.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
T.R.U.E. Test, TRUE TEST Diagnostic Patch Test
Rady Children's Hospital
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00795951
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.
The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.
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