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Study Results Support Ingenol Mebutate's AK Effectiveness

Phase III Trials Prove Efficacy of Ingenol Mebutate for Actinic Keratoses

The Food and Drug Administration approved two strengths of ingenol mebutate gel for the treatment of actinic keratoses Jan. 23.

The 0.015% formulation of ingenol mebutate gel (Picato) was approved for the treatment of lesions on the face and scalp once daily for 3 consecutive days; the 0.05% gel was cleared for once-daily treatment of the trunk and extremities for 3 consecutive days. The gel may be applied to the affected area, up to one contiguous skin area of about 25 cm².

Ingenol mebutate is taken from the milky sap of a plant called radium weed – or Euphorbia peplus – which has been used traditionally as a treatment for skin conditions. It is thought that the treatment induces cell death, but the mechanism of action isn’t fully understood.

Approval was supported by four double-blind, vehicle (placebo)-controlled trials of about 1,000 patients, two of which were done in the trunk and extremities and the other two in the neck and scalp.

In the trunk and extremity studies, ingenol mebutate gel had a complete clearance rate (100% of lesions gone) of 28% and 42%, compared with 5% for the vehicle control in both studies. Partial clearance rates (at least 75% of lesions cleared) were 44% and 55%, vs. 7% for the vehicle control in both studies.

In the face and scalp studies, the complete clearance rates were 37% and 47%, vs. 2% and 5% for controls. Partial clearance rates came in at 60% and 68%, vs. 7% and 8% for vehicle controls.

The most common adverse events were local skin reactions, application site pain, and application site pruritus.

Manufacturer LEO Pharmaceuticals is planning to launch in the United States at the end of the first quarter or the beginning of the second quarter, President and CEO John Koconis said in an interview.

"The Pink Sheet" and this news organization are owned by Elsevier.