Ingenol mebutate: a new option for actinic keratosis treatment

Actinic keratosis, one of the most common dermatological pathologies manifests as ultraviolet- or sun-induced macules, papules or plaques, and is considered a biomarker for the risk of skin cancer. Ingenol mebutate (Picato®), extracted from the sap of the Euphorbia peplus plant, is a small molecule with a unique mechanism of action involving direct cytotoxicity and immune stimulation. In 2012, ingenol mebutate was approved by the FDA and the EMA for the treatment of actinic keratosis. In phase III trials, ingenol mebutate gel applied topically once daily at 0.015% for 3 days or 0.05% for 2 days, respectively, significantly reduced head and non-head actinic keratosis lesions. Adverse events were mostly mild or moderate. Local skin responses elicited by the treatment, i.e., erythema, flaking/scaling and crusting, were transient, and resolved spontaneously without sequelae. Adherence to the therapy can be facilitated by the short duration of the treatment.