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Dermatol Ther (Heidelb). 2016 Dec;6(4):461-464. Epub 2016 Sep 19.

Use of Lesion Response Rate in Actinic Keratosis Trials.

Author information

1
Department of Dermatology and Allergology, Vest Clinic, Recklinghausen, Germany. Rolf-Markus.Szeimies@Klinikum-Vest.de.
2
Amaris, London, UK.
3
Innovaderm Research Inc., Montreal, QC, Canada.

Abstract

Complete patient clearance is often required by regulatory agencies for the approval of treatments for actinic keratosis (AK). However, an increasing number of clinicians have challenged the use of this measure in clinical practice and its interpretation. It has been argued that complete patient clearance often underestimates the clinical benefit of a drug and is influenced by a number of key confounding factors, such as number and distribution of lesions, at baseline. Lesions response rate is one alternative which has been suggested as more relevant due to its applicability to clinical practice and closer reflection of the clinical value of the drug. This paper provides an updated perspective on the topic and details the current thinking on the role of complete clearance and lesion response rate in the context of AK.

FUNDING:

Galderma.

KEYWORDS:

Actinic keratosis; Clinical practice; Clinical trial; Efficacy; Lesion clearance; Lesion response rate; Solar keratosis

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