Treating actinic keratosis, a skin condition that is the most common precursor to sun-related squamous cell carcinoma, can require months with current available therapies. Now, a new topical gel is available by prescription that significantly decreases the amount of treatment time, according to a multicenter phase 3 trial led by researchers at Mount Sinai School of Medicine. The newly approved gel, ingenol mebutate, is applied to the skin for just a few days, making treatment faster and even more effective. Study results were published in the March 15, 2012, issue of the New England Journal of Medicine.
The study results were improved or comparable to rates of current actinic keratosis clearance, yet patients required just 2 to 3 days of application with ingenol mebutate. Current topical medications used to treat actinic keratosis often result in skin irritation, and therefore many patients do not complete the full treatment regimen. However, the shorter 2- to 3-day treatment period resulted in 98% of patients in the study completing the full treatment regimen.
For the study, patients were divided into 2 groups. Group 1 included 547 patients with actinic keratoses on the face or scalp, and group 2 included 458 patients with actinic keratoses on the trunk or extremities. About half of each group received ingenol mebutate and the other half received a placebo. A treatment of ingenol mebutate at a .015% concentration was given to the first group for 3 days. The second group received a .05% concentration for 2 days. Upon study completion, 42% in the first group treated with ingenol mebutate and 34% in the second group showed complete clearance of actinic keratosis. In the placebo groups, approximately 4% and 5%, respectively, showed complete clearance.
“The shorter application period is what makes ingenol mebutate a breakthrough in the treatment of actinic keratosis,” said Mark Lebwohl, MD, lead study author, professor and chair of the Department of Dermatology at Mount Sinai School of Medicine. “Many patients find it difficult to stick with the current regimen. The shorter period is a more effective option for patients who don’t want a treatment that interferes with their everyday lives for weeks or even months.”
Source: Mount Sinai School of Medicine.