Understanding efficacy end-points in studies of field-directed therapy for actinic keratosis.

BACKGROUND

The rates of short-term clearance of actinic keratoses appear to be comparable in clinical trials of topical treatments used in field therapy, but direct comparisons of efficacy results can be problematic. Trials use different efficacy end points, have different study designs, involve different anatomic sites, and enroll different patient populations. In addition, because adherence in real-world clinical practice differs from that observed in clinical trials, conclusions drawn from efficacy outcomes can be misleading. The objective of this review was to examine the efficacy end points used in studies of topical therapy for actinic keratosis, address other factors influencing efficacy outcomes in these studies, and discuss the possible influence of nonadherence on effectiveness.

METHODS

Review of the available literature on topical therapy for actinic keratosis.

RESULTS

The end points used to determine efficacy of therapies for actinic keratosis include a disparate group of outcomes, which can often make comparison between studies impossible.

CONCLUSIONS

Efficacy end points of clinical studies designed to assess the treatment of actinic keratosis should be standardized to facilitate between-trial comparisons, and studies should focus on the end points that are most clinically relevant.