Study of the usefulness of patch testing and use test to predict the safety of commercial topical drugs.

Patch testing (PT) can be used to identify allergens and irritants responsible for contact allergic and irritant dermatitis, respectively. However, the reproducibility of PT and correlation between PT and use test has not been fully evaluated. The aim of the present study was to examine the reproducibility of PT and its usefulness in assessing the safety of topical drugs. A total of 55 topical drugs were applied to the backs of two groups of subjects for either 24 or 48 h, and skin irritant reactions were graded at 2 and 24 h after patch removal. For the repeat open application test, six topical drugs with different irritation scores were applied to the arms of two groups of subjects twice daily for 3 weeks, and local symptoms were recorded. The mean irritation scores were similar between the two PT groups. The percentage of subjects positive for symptoms provoked by the use tests was similar between the two groups. The mean irritation scores 24 h after patch removal correlated with the skin symptoms provoked by the use test. PT was reproducible and the results correlated with the use test results. PT is a useful method for evaluating the safety of commercial topical drugs.