FDA Approves T.R.U.E. Test Ready-To-Use Patch Test for Pediatric Use

Tuesday, September 12, 2017 | FDA Approval/Clearance , Pediatric


The FDA has approved SmartPractice's 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).

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."

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