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.