Topical Gel for Actinic Keratosis

February 2012, Vol 3, No 1 - FDA Approvals, News & Updates


The apoptotic topical gel ingenol mebutate (Picato; Leo Pharma) has received FDA approval for the treatment of actinic keratosis, a precancerous condition that can progress to squamous-cell carcinoma.

In 4 phase 3 studies involving >1000 patients with actinic keratosis, 60% to 68% of those with lesions on the face and scalp and 44% to 55%
of those with lesions on the trunk and extremities demonstrated ≥75% clearance after receiving ingenol. Among those who received placebo, only 7% to 8% demonstrated ≥75% clearance.

The recommended dose is 0.015% applied to lesions on the face or scalp once daily for 3 consecutive days and 0.05% applied to lesions on the trunk and extremities once daily for 2 days. (January 23, 2012)