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Diagnostics Dermatology FDA

 News Release - September 12, 2017

T.R.U.E. Test(R) Ready-To-Use Patch Test Receives FDA Approval For Pediatric Use

PHOENIX, Sept. 12, 2017 -- (Healthcare Sales & Marketing Network) -- SmartPractice has received FDA approval for T.R.U.E. TEST (truetest.com) ready-to-use patch test panels for pediatric patients as young as 6 years of age. T.R.U.E. TEST is the only FDA-approved product for diagnosing allergic contact dermatitis (ACD), a persistent skin rash caused by exposure to substances to which a patient is allergic. Symptoms of allergic contact dermatitis include itching, redness, swelling, cracking, scaling and crusting. Common causes of ACD include fragrances, preservatives, nickel, textile dyes and other substances which are frequently in contact with the patient's skin. Patch testing is the only way to accurately diagnose the cause of a patient's ACD.

ACD may affect as many as 20% of the pediatric population (Militello, et al 2006). The most common allergens causing ACD in children are nickel, topical antibiotics, preservative chemicals, fragrances and rubber accelerators. The frequency of ACD to many allergens tends to increase with age. The only way to effectively diagnose ACD is to perform a patch test.

Patch testing involves the application of panels containing individual test substances onto a patient's skin, most commonly the patient's back. The panels are worn for 48 hours, after which they are removed. The patient returns to the doctor's office for additional visits to have the results read and interpreted and to receive counseling on avoidance of allergic substances as appropriate.

"Our mission is to help identify the cause of a patient's contact dermatitis. Often, only the symptoms of ACD are treated by prescribing patients a course of corticosteroids. This approach may offer temporary relief of symptoms but will not resolve the problem. After many years of safety and efficacy studies, we are pleased to have received approval for our T.R.U.E. TEST product, which can now be used to help diagnose ACD in pediatric patients," said Dr. Curt Hamann, CEO and Medical Director of SmartPractice. "As clinicians it is our duty to make sure every patient receives the diagnosis they deserve."

Patch testing with T.R.U.E. TEST is available at a physician near you.

Visit: smartpractice.com/dermatology or myskinallergy.com to find a physician who performs patch testing in your area.

Dr. Hamann is available for interviews. High resolution images available, upon request.


Source: SmartPractice

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