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January 15, 2020

A Step Toward Standardizing Clinical Trials of Actinic Keratosis

Author Affiliations
  • 1Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
  • 2Mediprobe Research Inc, London, Ontario, Canada
  • 3Dr George Martin Dermatology Associates, Kihei, Hawaii
JAMA Dermatol. 2020;156(3):255-257. doi:10.1001/jamadermatol.2019.4210

The practice of medicine was revolutionized in 1992 with the introduction of the concept of evidence-based medicine.1 Since the advent of this movement, systematic reviews and meta-analyses not only have become popular but also have steered the development of clinical practice guidelines and supported justification of further research by granting agencies.2 By summarizing available data and comparing the effectiveness of multiple treatment alternatives, systematic reviews provide a high level of evidence quality on the clinical benefits and harms of interventions, which is highly desired in health care decision-making. However, inconsistency in the quantification of an outcome across trials deters the pooled estimation of the measure of effect. This lack of outcome uniformity is evident in the literature pertaining to interventions for actinic keratosis, hindering cross-trial comparisons of treatments and the identification of the most effective therapies.

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1 Comment for this article
Prevention of Progression to Keratinocyte Carcinomas in High-Risk Patients should be considered as a Measurable Outcome
Stuart Marcus, MD, Ph.D | Chief Medical Officer, SonALAsense, Inc.
I directed all clinical research for DUSA Pharmaceuticals from 1993 through 2017, receiving FDA approval for the first topical 5-ALA mediated photodynamic therapy (PDT) system in the United States for treatment of actinic keratoses in 1999. During that time I interacted with the FDA Division of Dermatology many times. I feel that Gupta et al are missing one of the most important, easily measured, and recently recognized outcomes of field-directed actinic keratosis treatment, which is the prevention of progression to keratinocyte carcinomas in high-risk populations.

Recent studies have shown that a single standard course of topical
5-Fluorouracil or 3 courses of topical 5-ALA PDT over the course of a year can significantly reduce the annual recurrence rate of actinic keratoses as well as the rate at which keratinocyte carcinomas arise in these patients (Weinstock, M et al, JAMA Derm, 154 (2) 167-74 2018 Feb 1; Piacquadio, D et al, J Drugs Dermatol, in press, respectively) . Due to the surge in population of individuals over 65 (baby boomers), considering prevention of actinic keratosis recurrence as well as chemoprevention of keratinocyte carcinomas could provide a huge cost savings to the Medicare budget by avoiding surgeries.