Short-Term Topical Treatment for Actinic Keratosis Approved

Martha Kerr


January 26, 2012

January 26, 2012 — The US Food and Drug Administration has approved ingenol mebutate gel (.015% and .05%; Picato, LEO Pharma) in a treatment course that can be as short as 2 or 3 days for the treatment of actinic keratosis (AK).

The .015% strength is approved for use once daily on the face and scalp for 3 consecutive days, and the 0.05% strength is approved for use once daily on the trunk and extremities for 2 consecutive days.

In a release, the company states that the product is "the first and only topical therapy for [AK] that can be used for as little as two or three days."

According to the American Academy of Dermatology (AAD), 1 in 5 Americans will develop skin cancer, and approximately 65% of squamous cell carcinomas begin as untreated AK. AAD statistics indicate that "60% of predisposed persons older than 40 have at least one actinic keratosis."

"Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical," said Mark Lebwohl, MD, from the Department of Dermatology, Mount Sinai Medical Center, New York City, in the company's news release. "What makes this new solution particularly exciting is the two or three day course of treatment." Dr. Lebwohl was an investigator in 1 of the 4 studies on which the approval was based.

The studies leading to the approval involved more than 1000 patients with AK. Significantly more patients treated with the gel had complete clearance of lesions compared with those receiving placebo. The most common adverse events were local skin reactions including erythema, flaking/scaling, crusting, and swelling.


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