Picato Gel (ingenol mebutate, 0.015% and 0.05%) was recently approved by the US FDA for the treatment of actinic keratosis (AK). Picato Gel is applied to the skin and is available only by prescription.
Picato Gel is the first topical therapy to effectively treat actinic keratoses in just two or three days.
Dr. Mark Lebwohl, M.D., chairman, Department of Dermatology, Mount Sinai Medical Center in New York City and investigator of one of the clinical studies of ingenol mebutate commented in a statement for the Skin Cancer Foundation that “what makes this new solution particularly exciting is the two or three day course of treatment.”
The active ingredient, ingenol mebutate, is derived from the sap of a plant called “radium weed” (Euphorbia peplus). It is thought that the chemical ingenol causes the death of abnormal skin cells, but the mechanism of action isn’t fully understood.
The 0.015% formulation of Picato was approved for the treatment of lesions on the face and scalp once daily for 3 consecutive days. The 0.05% formulation (stronger concentration) was cleared for once daily treatment of the trunk and extremities for 3 consecutive days.
The four different phase III clinical studies performed on ingenol mebutate reported that a significantly higher proportion of those treated with Picato gel showed complete clearance of AKs when compared to placebo.
“Cryotherapy (freezing of the skin lesion) has been the gold standard for actinic keratosis for some time, with topical agents also used over a period of weeks to months,” said Neil Swanson, M.D., Department Chairman and Professor of Dermatology at OHSU and principal investigator of one of the clinical studies (REGION-I) in a press release published by the manufacturer LEO pharmaceuticals. Dr. Swanson added that “Findings from the REGION-I study suggest that PEP005, a topical Gel administered over just two days, may provide a safe and effective alternative to current therapies.”
In the face and scalp studies, the complete clearance rates were 37% and 47%, vs. 2% and 5% for controls. Partial clearance rates came in at 60% and 68%, vs. 7% and 8% for vehicle controls.
The most common side effects following the use of Picato Gel were local skin reactions (redness, irritation), and pain and itching at the application site.
Actinic Keratoses (“solar keratoses”) are precancerous skin lesions that may appear as scaly or crusty growths (lesions). AKs are caused by overexposure to the ultraviolet rays (UV-rays) of the sun. AKs usually appear on sun-exposed areas such as the face, bald scalp, lips, and the back of the hands. If left untreated, actinic keratoses can become a type of skin cancer called squamous cell carcinoma.
According to Dr. Mark Lebwohl of Mt. Sinai “Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of (AK) lesions are critical,”