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.
Neil Swanson M.D. of Oregon Health and Science University noted two benefits in the use of ingenol mebutante gel. First, the skin reaction, which was most noticeable on the face on day 4, had resolved by day 15, demonstrating a quick recovery of irritation from the medication.
"Second, the short duration of treatment may result in very high (>98%) adherence to the therapy, contributing to the effectiveness of ingenol mebutate." (2)
It was assessed that day 57 was the peak endpoint of maximum amount of AK clearance. Of the 108 ingenol mebutate patients that were followed for an additional 12 months, 87 percent of these patients continued to have cleared lesions.
1. Lebwohl M et al. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. Retrieved Mar. 17, 2012. Abstract
Department of Dermatology, Mount Sinai School of Medicine, New York, USA
2. Gel Quickly Clears Actinic Keratosis By Charles Bankhead, Staff Writer, MedPage Today Published: March 14, 2012. Retrieved Mar. 17, 2012.
3. New Actinic Keratosis Treatment Approved by the FDA. Retrieved Mar. 17, 2012.
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith