2013 Re: T.R.U.E Test and gold Dear Health Care Professional ...

Ten (10) studies were conducted in North America and Europe to evaluate the effectiveness, frequency of patch reactions, and/or sensitivity and specificity,and/or agreement with a reference allergen (when used) of T.R.U.E. TEST used to diagnosis allergic reactions to one or more substances in the panels in adults.Subjects ranged in age from 18 through 86 years. Subjects with suspected allergic contact dermatitis, based on history or clinical signs, were tested in allstudies. The allergens tested in each of the studies are noted in Table 1 [see Adverse Reactions (6.1)].Study No. 1This study evaluated the efficacy of T.R.U.E. TEST Panel 1.1. A total of 127 subjects with suspected contact dermatitis were recruited. T.R.U.E. TEST Panel 1.1,containing 12 allergens (no negative control was on the original Panel 1) was applied to the subject’s back and remained there for 48 hours. The results wereevaluated after 48 and 72 to 96 hours. Forty-five (45) subjects showed a total of 65 reactions to 11 of the 12 allergens in Panel 1.1. There were positive testreactions to all allergens except potassium dichromate. See Table 4.Study No. 2This study evaluated the efficacy of T.R.U.E. TEST Panel 2.1. A total of 121 subjects with suspected contact dermatitis were recruited. T.R.U.E. TEST Panel 2.1,containing 11 allergens and a negative control, was applied to the subject’s back and remained there for 48 hours. The results were evaluated after 72 to96 hours. Thirty-two (32) subjects showed a total of 46 positive test reactions. There were positive responses to all of the allergens except quinoline mix andparaben mix. See Table 4.40