Track topics on Twitter Track topics that are important to you
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 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
- Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
- Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
- Concordance/discordance as compared to the corresponding reference petrolatum allergen.
To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
- The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning.
- The frequency and characterization of adverse events and serious adverse events.
- The frequency and characterization of late and/or persistent reactions.
Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Dermatology Specialists PSC
Published on BioPortfolio: 2014-08-27T03:32:00-0400
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...
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...
An open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens.
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
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...
To detect common skin-sensitizing agents among patients experiencing allergic contact dermatitis (ACD). Methods: This was a retrospective study of 152 patients with clinically suspected ACD who under...
Patch-test readings after day 5 have previously been used to identify delayed reactions to metals and topical antibiotics.
Studies have shown that not all positive patch test reactions are reproducible upon retesting, that is, persistent. Non-persistent reactions might represent initial false-positive reactions, meaning t...
Chronic idiopathic urticaria (CIU) is one of the mysteries of dermatology. An association between spontaneous CIU and contact allergy sensitization is possible. In this study, we aimed to test the hyp...
A 33-year-old woman presented to our clinic for suspected photoallergic contact dermatitis with a recent episode of severe, vesicular dermatitis involving exposed skin and correlating with relocation ...
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.
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...
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...