Efficacy of Ingenol Mebutate in the Treatment of Actinic Keratoses: A Pre- and Posttreatment Dermoscopic Comparative Analysis

Abstract

Actinic keratosis (AK) is a common skin lesion in adults which usually occurs on chronically photoexposed areas and considered as a precancerous lesion or a superficial squamous-cell carcinoma. Many classifications have been proposed and its diagnosis is generally clinical but, sometimes, its wide variety of presentations can make diagnosis difficult, even among expert observers. The malignant potential of AKs imposes an early diagnosis and treatment in order to reduce morbidity and mortality, and, for the characterization of photodamaged skin, noninvasive diagnostic techniques, such as dermoscopy, have proved to be useful, while multiple therapeutic strategies, lesion-directed versus field-directed therapies, are available for the treatment of AKs. In this study, we evaluated the efficacy of ingenol mebutate for the treatment of AKs, with a particular focus on patients' compliance, correlating it to clinical and dermoscopic grading, pre- and posttreatment, of these lesions. Fifty-two enrolled patients with AKs received treatment with ingenol mebutate gel (0.015% for face and scalp; 0.05% for trunk and extremities) and multiple dermatological evaluations. End points of the study were complete and partial clearance of clinically visible AKs on day 90. All acquired data were recorded and statistical analyses were performed. Univariate and multivariate analyses were used to identify possible predictive factors. We retrospectively analyzed patient-related and lesion-related factors to identify which variables, among age, gender, lesion site, pain, LSR score, and pretreatment clinical and dermoscopic grading, could independently predict the response to ingenol mebutate treatment. Our findings showed that pretreatment dermoscopic grade II represents an independent predictive factor of the efficacy of ingenol mebutate therapy (OR=14.78, 95% CI: 1.83–119.59, P=0.012) and that response rates differ on the basis of the treated anatomical sites (OR=0.16, 95% CI: 0.03–0.85, P=0.031). Data from this study provide evidence that ingenol mebutate gel is an effective treatment for AK, with relative ease of use, short exposure, and rapid resolution of local reactions, benefits contributing to high adherence of this therapy. Moreover, dermoscopic analysis of skin lesions offers more information than clinical evaluation alone and can be helpful in identifying different groups of AKs, thus selecting the adequate therapeutic choice.

Patient-centered management of actinic keratosis. Results of a multi-center clinical consensus analyzing non-melanoma skin cancer patient profiles and field-treatment strategies

“…[12,16] For many cases of AK, several treatment approaches are potentially suitable based on existing guidelines. This document therefore further complements existing guidelines and previous consensus papers by providing recommendations about selecting the appropriate Ingenol mebutate was one of the treatment options proposed for many of the profiles and this was driven by its association with good cosmetic outcomes [17,18] ; the predictable nature of the treatment and related short-term local skin reactions [19][20][21][22] ; and the fact that the administration regimen of ingenol mebutate allows for flexible use, as patients are able to decide how and when it is used according to their needs and individual condition. In a randomized, evaluator-blinded trial of ingenol mebutate 0.015% gel and diclofenac sodium 3% gel, patients experienced a shorter duration of skin reactions, with a peak after one week, with ingenol mebutate compared with diclofenac sodium, who experienced reactions throughout the 90-day treatment.…”