Expert Consensus on Cosmetic Outcomes After Treatment of Actinic Keratosis

March 2017 | Volume 16 | Issue 3 | Original Article | 260 | Copyright © 2017

Brian Berman MD PhD,a Glynis R. Ablon MD,b Neal D. Bhatia MD,c Roger I. Ceilley MD,d David J. Goldberg MD JD,e Mark S. Nestor MD PhD,a and Susan H. Weinkle MDf

aUniversity of Miami, Miller School of Medicine, Miami, FL bUCLA Medical Center, Los Angeles, CA cTherapeutics Clinical Research, San Diego, CA dUniversity of Iowa, West Des Moines, IA eMount Sinai School of Medicine, New York, NY fUniversity of South Florida, Tampa, FL

Abstract

Dermatologists treat actinic keratosis (AK) primarily because these lesions have the potential to progress to invasive squamous cell carcinoma. Patients, on the other hand, generally seek treatment to remove the lesions and achieve an improved appearance of their skin following treatment. In selecting a treatment option for AK, dermatologists should consider post-treatment cosmesis, because cosmetic outcomes differ across AK treatments. To obtain expert opinion on the cosmetic sequelae related to chronically photodamaged skin and the treatment of AK, an expert panel meeting among dermatologists was conducted in February 2016. These experts reviewed current treatment options for photodamage, including AK, and discussed the relative merits of the various cosmetic assessments commonly used by investigators and patients in both clinical trial and dermatology practice settings. A main goal of the expert panel meeting was to propose assessment tools that could be specifically designed to characterize cosmesis results after treatment of AK. The panel agreed that existing tools for measurement of cosmetic outcomes following treatment of photodamage could also be used to evaluate cosmesis after treatment of AK. Digital photography is probably the best method used for this, with validation by other technologies. Better measurement tools specifically for assessing cosmesis after AK treatment are needed. Once they are developed and validated, regulatory agencies should be educated about the importance of including cosmetic outcomes as a component of product labeling.

J Drugs Dermatol. 2017;16(3):260-265.

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INTRODUCTION

Actinic keratosis (AK) is a marker for photodamaged skin.1 Dermatologists treat AKs primarily because these lesions have the potential to progress to invasive squamous cell carcinoma (SCC). Most patients seek treatment to remove the lesions and achieve improved cosmesis of the skin following treatment.2 When determining which treatment to use in a patient presenting with AK, dermatologists generally consider a variety of factors, such as patient preference, cost and availability of treatment, location of lesions, tolerance for adverse events, and the need for field therapy (ie, the number of lesions in a discrete area).3,4 Cosmesis following treatment should also be considered, especially for patients who are particularly concerned about their skin’s appearance, because cosmetic outcomes differ across AK treatments.5 However, there is only limited research on cosmetic outcomes following treatment of AK, hindered by the absence of reliable, reproducible, and valid, condition-specific assessments, including patient-reported outcome (PRO) instruments.6,7 Currently available outcome measures of cosmesis are specific for photodamage, not AKs.To address the subject of cosmetic outcomes following treatment of AK, an expert panel of seven dermatologists was convened in Miami, Florida, on February 11, 2016. The objectives of the meeting were to (1) define cosmesis in the context of AK from clinicians’ and patients’ perspectives, (2) review current management options for photoaging and AK, (3) analyze currently available cosmetic outcome assessment methods used by investigators and clinicians, especially in terms of their utility, and (4) propose optimal assessment tools for cosmesis following treatment of AK and outline a strategy for validation and future application of these tools in clinical research that would be acceptable to regulatory agencies.This article summarizes the panel’s discussions on photoaging, AKs, treatment, and cosmesis assessments, including their personal clinical experience and evidence from the published literature.Photoaging The skin is the only organ that is chronically exposed to the environment.8 Chronologic, or biologic skin changes (intrinsic

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