More than 40 percent of patients had complete clearance of actinic keratosis, according to the pooled data from four multi-center placebo-controlled trials using Picato gel (ingenol mebutate).
These results were published in the New England Journal of Medicine March 15, 2012 issue. (1)
The U.S. Food and Drug Administration officially approved the use of Picato gel (ingenol mebutate) for the treatment of actinic keratosis (AK) in January 2012 after Leo Pharma, the manufacturer, had successfully completed the required clinical trials.
Actinic keratosis is a potentially dangerous skin lesion as it can lead to squamous cell skin cancer. “According to the Academy of Dermatology (AAD) one in five Americans will develop skin cancer in their lifetime and studies show that 65% of squamous cell cancer began as untreated actinic keratosis.” (3)
While there are alternative treatments to treat AK, none are as fast-acting as ingenol mebutante gel. Cryosurgery can cause scarring and recurrence is common. Other topical medications require longer treatment, sometime months of daily treatments, and can cause a more severe inflammatory response.(3)
The trials, funded by Leo pharma, involved pooled data from two groups that had their face or scalp treated and two groups that had their trunk or extremities treated. There were 547 patients in the face/scalp group and 458 in the trunk/extremity group, with 98 percent completing the study protocol.
The face/scalp group was treated with .015 percent gel once a day for three consecutive days. The trunk extremity group was treated with .05 percent gel once a day for two consecutive days.
The rate of complete clearance was higher in the ingenol mebutante gel group at 42 percent compared to the placebo group at 3.7 percent after two or three consecutive days of treatment in the face/scalp group.
In the trunk/extremity group, the rate of complete clearance was also higher in the ingenol mebutante gel group by 34.1 percent versus the placebo group, which only had a 4.7 percent clearance.
Both groups did show some local skin reaction of irritation, which resolved within a matter of days in both groups.