Picato® Gel Approved

First Therapy to Treat Actinic Keratosis in Two to Three Days

The US Food and Drug Administration (FDA) has approved a new treatment for actinic keratosis (AK), a common skin precancer that affects 58 million Americans. Leo Pharmaceuticals’ Picato® (ingenol mebutate) gel (0.015% and 0.05%) is the first topical therapy to effectively treat AKs in just two or three days. 

AKs, also called solar keratoses, are scaly or crusty growths (lesions) caused by damage from the sun’s ultraviolet rays. They typically appear on sun-exposed areas such as the face, bald scalp, lips, and the back of the hands. If untreated, AKs can become squamous cell carcinomas, common skin cancers that can be locally destructive and occasionally life-threatening. Picato® 0.015% gel is applied to the face and scalp once a day for three consecutive days, and the more concentrated Picato® 0.05% gel is applied to the trunk and extremities once a day for two consecutive days.

“Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical,” said ingenol mebutate study investigator Mark Lebwohl, MD, chairman, Department of Dermatology, Mount Sinai Medical Center, New York City,  and a member of The Skin Cancer Foundation’s Medical Council. “What makes this new solution particularly exciting is the two or three day course of treatment.”

In phase III clinical trials, 60-68 percent of patients with AKs on the face and scalp and 44-55 percent with AKs on the trunk and extremities saw a 75 percent or greater reduction in existing lesions with Picato®. Complete clearance rates ranged from 28-42 percent (the trunk and extremities) to 37-47 percent (face and scalp). In contrast, just 7-8 percent of AK patients receiving a placebo experienced 75 percent or more reduction in lesions on the face/scalp or trunk/extremities; complete AK clearance among these patients did not exceed five percent.

The most common side effects of Picato® were skin redness, flaking/scaling, crusting and swelling.