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.