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Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

09:11 EDT 24th April 2014 | BioPortfolio

Summary

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

Description

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Dermatitis, Contact

Intervention

T.R.U.E. Test, TRUE TEST Diagnostic Patch Test

Location

Rady Children's Hospital
San Diego
California
United States
92123

Status

Completed

Source

Allerderm

Results (where available)

View Results

Links

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.

A standard and widely accepted diagnostic test used to identify patients who have a vasodepressive and/or cardioinhibitory response as a cause of syncope. (From Braunwald, Heart Disease, 7th ed)

A projective test used to evaluate a broad range of personality variables including pathology of thought and perception. The subject's responses to inkblot prints are scored along with subjective interpretation by the test administrator.

A diagnostic test in which vitamin B12 is tagged with radioactive cobalt, taken orally, and gastrointestinal absorption is determined via measurement of the amount of radioactivity in a 24-hour urine collection.

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