Ingenol mebutate gel is effective treatment for actinic keratosis, study shows

Ingenol mebutate topical gel (0.015% for face and scalp and 0.05% for trunk and extremities) was effective for treating actinic keratoses, a common precursor to sun-related, squamous cell carcinoma, according to a new study.

The 4-multicenter, randomized, double-blind study, published in the March 15 issue of the New England Journal of Medicine, was led by Mark Lebwohl, MD. The study was funded by LEO Pharma.

In the study, patients with actinic keratoses on the face or scalp, or on the trunk or extremities, were randomly assigned to receive ingenol mebutate (Picato, LEO Pharma) or a placebo. Patients self-applied the medication or placebo to a 25-cm² contiguous area once daily for 3 consecutive days for lesions on the face and scalp or for 2 consecutive days for lesions on the trunk or extremities.

Complete clearance (primary outcome) was assessed at 57 days, and local reactions were quantitatively measured.

The researchers found that the rate of complete clearance on the face and scalp was higher (42.2%) with ingenol mebutate than with placebo (3.7%). The rate of complete clearance on the trunk and extremities was 34.1% with ingenol mebutate versus 4.7% with the placebo. In addition, adverse events were generally mild to moderate in intensity.