Safety and tolerability of ingenol mebutate in the treatment of actinic keratosis.

INTRODUCTION: Ingenol mebutate is a topical therapeutic agent for the treatment of actinic keratosis (AK). It has a novel mode of action and has shown comparable efficacy to other topical field therapies. This article summarizes and provides perspective on the safety profile of ingenol mebutate from clinical studies of this agent. AREAS COVERED: The unique mechanism of action of ingenol mebutate, the basis for a rapid clinical effect, is outlined. Safety and tolerability data, including mean composite local skin response (LSR) scores, type of LSR, and adverse events from a range of clinical studies both in healthy volunteers and patients with AK, are reviewed. The safety profile of ingenol mebutate is then compared with other agents used to treat AK lesions. EXPERT OPINION: Ingenol mebutate has a dosing period of 2 - 3 days, which is short compared with other field therapies, and there is no evidence of systemic absorption. The fact that most of the LSRs observed are mild to moderate in intensity and transient, with a majority resolved within 2 weeks, makes for a favorable safety profile. Ingenol mebutate enhances the armamentarium available to the dermatologist for the treatment of AK.