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
The study is required by the FDA as part of a post-marketing commitment. The purpose of the study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use exposure....
We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 ...
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, Hydrocortison...
An open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens.
The current knowledge of the pathophysiology of allergic contact dermatitis is based on the murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the re...
Debate surrounds the validity of patch testing for allergic contact dermatitis in patients taking immunosuppressants and the extent to which these medications suppress patch test reactions. Previous s...
This study aimed to examine the association between piercing and patch test sensitivity to metals (nickel, cobalt, and chromium) in North America.
The length of time between onset of symptoms and definitive diagnosis is associated with outcomes in contact dermatitis (CD). Understanding the health care experience of patients with CD could identif...
Background:As the use of sunscreens becomes more prevalent, reports of adverse effects to sunscreens have increased.Objective:To analyze a patch test database for the prevalence of allergic contact de...
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.