Advertisement

Topics

Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

2014-08-27 03:32:00 | BioPortfolio

Summary

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.

Description

Primary endpoint:

The performance (efficacy) of each allergen 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. Performance will be based on:

- Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens.

- Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:

- The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period.

- The frequency of adverse events and serious adverse events.

Study Design

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

Conditions

Contact Dermatitis

Intervention

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Location

River City Dermatology
Little Rock
Arkansas
United States
72205

Status

Completed

Source

Allerderm

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:00-0400

Clinical Trials [5663 Associated Clinical Trials listed on BioPortfolio]

Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

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 ...

Evaluating for Contact Allergies in Patients With Chronic Urticaria

Hives affects 10-25% of the population worldwide at some time during their lifetime. Hives are itchy transient swellings of the skin lasting 4-36 hours. Chronic urticaria is defined as hiv...

Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

An open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens.

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

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

The primary objectives of this study are to identify positivity rates to three novel surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower the surface...

PubMed Articles [24093 Associated PubMed Articles listed on BioPortfolio]

28 days follow up of patch-test reactions to p-phenylenediamine and p-phenylenediamine dihydrochloride: a multicenter study on behalf of EECDRG.

It is discussed if routinely patch testing p-phenylenediamine (PPD) 1.0 % petrolatum is safe due to the risk of patch test sensitization. Late appearing patch test reactions may reflect patch test sen...

Patch Testing Pearls.

Dermatitis is one of the most common illnesses encountered by healthcare providers and the causes are numerous. Contact dermatitis is the form of dermatitis resulting from contact with the environment...

Trends in Patch Testing With the Mayo Clinic Standard Series, 2011-2015.

Patch testing to a standard (baseline) series of allergens is the screening tool used to identify culprit allergens in patients with contact dermatitis. The allergens and concentrations used in a stan...

"Slime" contact dermatitis: Case report and review of relevant allergens.

Homemade "slime" is currently a popular childhood hobby that can cause allergic and irritant contact dermatitis. We describe a case of hand dermatitis due to homemade "slime" with a positive patch tes...

North American Contact Dermatitis Group Patch Test Results: 2015-2016.

Patch testing is an important diagnostic tool for the assessment of allergic contact dermatitis (ACD).

Medical and Biotech [MESH] Definitions

A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.

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)

An in vitro allergen radioimmunoassay in which allergens are coupled to an immunosorbent. The coupled allergens bind the IgE in the sera of patients which in turn binds radioisotope-labeled anti-IMMUNOGLOBULIN E antibodies.

Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.

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.

More From BioPortfolio on "Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Dermatitis
Dermatitis means an inflammation of the skin. Contact dermatitis is a term used when this inflammation is caused by contact with something in the environment. The changes of dermatitis seen in the skin take the form of eczema; hence it may sometimes be r...


Searches Linking to this Trial