Clinical trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says.

The guidance advises researchers to use static scales, such as current state and noncomparative methods to evaluate signs of cutaneous issues such as erythema, edema and erosion. Patient-reported outcome measures should be used to assess symptoms such as pruritus or burning.

Trials should plan the timing and frequency of assessments to identify anticipated reactions and characterize suspected adverse reactions using patch or photopatch testing with the active and excipient ingredients as well as the finished product.