Ingenol Mebutate Gel 0.015% and 0.05%

Abstract

Ingenol mebutate is the main active constituent of sap from the plant Euphorbia peplus, which has traditionally been used as a home remedy for various skin conditions. Ingenol mebutate gel is approved in the US, EU, Australia and Brazil for the topical treatment of actinic keratosis. A short course of field-directed therapy with topical ingenol mebutate gel was effective in the treatment of actinic keratoses on the face or scalp (ingenol mebutate gel 0.015% once daily for 3 consecutive days) and on the trunk or extremities (ingenol mebutate gel 0.05% once daily for 2 consecutive days), according to the results of four randomized, double-blind, vehicle-controlled, multicentre studies. Significantly higher complete clearance rates (primary endpoint) and partial clearance rates were seen at day 57 in patients receiving ingenol mebutate gel than in those receiving vehicle gel. Treatment with ingenol mebutate gel was generally associated with sustained clearance of actinic keratoses in the longer term. Topical ingenol mebutate gel was generally well tolerated in the treatment of patients with actinic keratoses on the face or scalp and on the trunk or extremities. Application-site conditions were the most commonly occurring adverse events.