Safety and efficacy evaluation of TRUE test panels 1.1, 2.1, and 3.1 in children and adolescents

Background: The Thin-layer Rapid Use Epicutaneous (TRUE) Test has approval for adults. Objective: To evaluate the efficacy and safety of TRUE Test panels 1.1, 2.1, and 3.1 in children and adolescents suspected of having allergic contact dermatitis (ACD). Methods: An open-label prospective study was performed, analyzing 102 consecutive patients aged 6 to 18 years referred for suspected ACD, between December 2008 and October 2009. Patch tests were applied for 48 hours, and evaluations of skin reactions were conducted at days 3 and 7, with a follow-up visit 3 weeks after the initial applications. Results: The mean age of all enrolled subjects was 11.6 years, and subjects included 52% females and 48% males. Positive reactions noted in more than 10% of the children were to nickel sulfate (29.7%), p-tert-butylphenol formaldehyde resin (16.8%), wool alcohols (15.8%), fragrance mix (12.9%), and cobalt dichloride (12.9%). Of the 101 subjects, 77 (76.2%) tested positive to one or more of the 28 allergens. No meaningful differences were observed in the frequency or severity of adverse events; reports of burning and stinging following patch removal; or the frequency, intensity, or symptoms of persistent reactions when evaluated by age, sex, or race. Conclusion: Patch testing is efficacious and safe in the pediatric population.