Research & Development
SmartPractice awarded US FDA approval for T.R.U.E. Test ready-to-use patch test in paediatric patients
13 September 2017 -

SmartPractice reported on Tuesday the receipt of the US FDA approval for T.R.U.E. TEST ready-to-use patch test panels for paediatric patients as young as six years of age.

The company said the T.R.U.E. TEST is the only US 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. The common causes of ACD include fragrances, preservatives, nickel, textile dyes and other substances which are frequently in contact with the patient's skin.

According to the company, the only way to accurately diagnose the cause of a patient's ACD is through patch testing with T.R.U.E. TEST at physician clinic.

In conjunction, the 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, added the company.