Ingenol mebutate gel is an effective treatment for actinic keratoses on the head and body, according to a study published in the March 15 issue of the New England Journal of Medicine.
To investigate the efficacy and safety of ingenol mebutate gel for actinic keratosis, Mark Lebwohl, M.D., of the Mount Sinai School of Medicine in New York City, and colleagues analyzed data from four multicenter studies in which patients with actinic keratoses on the face and scalp or on the trunk and extremities were randomly assigned to receive ingenol mebutate gel or placebo.
The researchers found that, in a pooled analysis of two studies involving the face and scalp, treatment with ingenol mebutate resulted in a significantly higher rate of complete clearance, compared with placebo (42.2 versus 3.7 percent). Local reactions peaked at day four, with a mean maximum composite score of 9.1 on the local-skin response scale, then fell quickly by day eight, and continued to drop, nearing baseline scores by day 29. In a pooled analysis of the two trials involving the trunk and extremities, a significantly higher rate of complete clearance was seen with ingenol mebutate versus placebo (34.1 versus 4.7 percent). Local skin reactions peaked between days three and eight, reaching a mean maximum score of 6.8, and decreased rapidly thereafter, coming close to baseline scores by day 29. Adverse events, which were usually of mild-to-moderate intensity, resolved without sequelae.
"Ingenol mebutate gel applied topically for two to three days is effective for field treatment of actinic keratosis," the authors write.
The study was funded by LEO Pharma, which manufactures ingenol mebutate gel; several authors disclosed financial relationships (including employment) with LEO.
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For more information on actinic keratosis treatment, read the article "Progression of Actinic Keratosis to Squamous Cell Carcinoma Revisited: Clinical and Treatment Implications."