Journal of Clinical and Aesthetic Dermatology

Ingenol Mebutate Topical Gel 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S3 JCAD journal of clinical and aesthetic dermatology November 2016 • Volume 9 • Number 11 Ingenol Mebutate Topical Gel A Status Report On Clinical Use Beyond Actinic Keratosis Abstract Ingenol mebutate is available as a topical gel formulation approved for the treatment of actinic keratosis. Two different concentrations are available for treatment of actinic keratoses at specific anatomic sites with the advantages of short durations of therapy and limited "down time" related to visible inflammation as compared to other topical agents. Due to the various modes of action of ingenol mebutate, it has also been used for treatment of disease states other than actinic keratosis. This manuscript discusses the suggested modes of action of ingenol mebutate and reviews publications on the use of ingenol mebutate gel for cutaneous disorders other than actinic keratosis, including squamous cell carcinoma in-situ, basal cell carcinoma, actinic cheilitis, anogenital warts, and others. Author commentaries are also included with the goal of providing relevant clinical insights. Introduction Ingenol mebutate (IM) is a diterpene ester extracted from the sap of the Euphorbia peplus plant that has a long history of medicinal use. 1 A topical gel formulation of ingenol mebutate (IMG), available in two concentrations, is approved by the United States Food and Drug Administration (FDA) and currently available for treatment of actinic keratosis (AK) involving the face or scalp (0.015% applied once daily for 3 days) and trunk or extremities (0.05% applied once daily for 2 days). 1–3 A summary of studies between 2009 and 2012 for AKs was inclusive of data from trials with IMG completed in 1,285 patients, with several other studies of IMG for AKs also summarized in the literature that support its efficacy and safety. 1,4 One obvious advantage associated with use of IMG for field treatment of AKs is the shorter durations of application by patients as compared to other available topical therapies for AK. 1 A second advantage is the shorter duration of visible inflammation at sites of application, reported in clinical studies as local skin reactions (LSRs), as compared to use of topical 5-fluorouracil (5-FU) and topical imiquimod. 1,3 Over time, the modes of action that are believed to be responsible for the therapeutic activity of topically applied IM have emerged in the literature and are summarized in Table 1. 4–11 It is important to recognize that IM exhibits the capability for therapeutic efficacy for AKs and also for other dermatologic disorders due to its ability to induce both an acute necrosis phase and a delayed inflammatory- immunologic phase, the latter believed to be important for both the early efficacy and potential substantivity of therapeutic benefit. 1,4–6,12 As noted above, the suggested modes of action of IM that have been reported are summarized in Table 1 and support use beyond the FDA- approved indication of AK. The following reviews literature on IMG used for treatment of a variety of dermatologic James Q. Del Rosso, DO, FAOCD, FAAD Adjunct Clinical Professor (Dermatology), Touro University Nevada, Henderson, Nevada; Research Director, Del Rosso Dermatology Research Center, Las Vegas, Nevada

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