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

Authors

  • John E. Wolf Jr MD, MA,

    Corresponding author
    1. Department of Dermatology, New York University Medical Center, New York, NY, USA
    • Department of Dermatology, Baylor College of Medicine, Houston, TX, USA, USA
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  • Darrell S. Rigel MD

    1. Department of Dermatology, New York University Medical Center, New York, NY, USA
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  • Disclosures: Dr Wolf has served as a speaker for LEO Pharma, PharmaDerm, and Sanofi-Aventis (Dermik). He has also been a consultant to Peplin (now LEO Pharma), and has participated in advisory boards for and has been a consultant to and speaker for Galderma. Dr Rigel has participated in advisory boards for and has been a consultant to and speaker for Graceway. He has also served as a consultant to Peplin (now LEO Pharma), Galderma, and Pharmaderm.

Correspondence

John E. Wolf Jr, md, ma

Department of Dermatology

Baylor College of Medicine

1709 Dryden – Suite 1050

Houston

TX 77030

USA

E-mail: jwolf@bcm.edu

Abstract

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.

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