Topically applied ingenol mebutate may be an effective field treatment for actinic keratoses, according to study results.
Researchers administered ingenol mebutate to patients with actinic keratoses in four multicenter, randomized double blind studies. Two trials involved lesions on the face or scalp (n=547); the others involved lesions on the trunk or extremities (n=458). Participants self-applied either ingenol mebutate gel or a placebo to a 25-cm2 area once daily in a 0.015% concentration for 3 consecutive days in the face/scalp group, with 277 participants receiving the drug and 270 receiving a placebo. In the trunk/extremities group, participants applied a 0.05% concentration of the gel (n=226) or a placebo (n=232) for two consecutive days. Investigators evaluated clearance and local reactions to the substance.
Complete clearance from ingenol mebutate was higher than with a placebo in both the face/scalp trials (42.2% vs. 3.7%; P,.001) and the trunk/extremities trials (34.1% vs. 4.7%; P,.001). Local reactions to the drug peaked on day 4, decreased by day 8 and approached baseline by day 29 in the face/scalp trials. In the trunk/extremities groups, reactions peaked between the third and eighth days and decreased quickly, reaching baseline by the 29th day. The mean maximum composite score was 9.1 on the local-skin-response scale in the face/scalp group and 6.8 in the trunk/extremities group. Mild to moderate adverse effects were reported and included pruritus, irritation and pain at the application site.
“The data from these four controlled studies provide evidence that ingenol mebutate gel is an effective treatment for actinic keratoses on the head and body, with local reactions of generally low-to-intermediate intensity and short duration,” researchers concluded.