The FDA has approved Picato® (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis, a precancerous condition caused by cumulative sun exposure that has the potential to progress to squamous cell carcinoma (SCC), the second most common type of skin cancer. The gel is applied once daily on the face and scalp for three consecutive days, and the 0.05% gel is used once daily on the trunk and extremities for two consecutive days.

The gel has been evaluated in four phase III studies in over 1000 patients that reported a higher proportion of complete clearance of the keratosis in the field of treatment as compared to placebo (n=502). The most common adverse events were local skin reactions, including erythema, flaking/scaling, crusting and swelling.