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Ingenol Mebutate Gel Approved for Actinic Keratosis

TOP - February 2012, Vol 5, No 1 published on February 28, 2012 in FDA Updates

Picato (ingenol mebutate; LEO Pharma) gel was approved in January by the FDA for the topical treatment of actinic keratosis (AK) on the face, scalp, trunk, and extremities. AK is a precancerous condition caused by cumulative sun exposure that has the potential to progress to squamous cell carcinoma, which is the second most common type of skin cancer. AK is a dry, scaly, rough-textured patch or lesion that forms on the outermost layer of the skin after cumulative exposure to ultraviolet light, including sunlight. Ingenol mebutate 0.015% gel is used once daily on the face and scalp for 3 consecutive days, and ingenol mebutate 0.05% gel is used once daily on the trunk and extremities for 2 consecutive days.

In four phase 3 clinical studies of more than 1000 patients with AK, a higher proportion of those treated with ingenol mebutate gel (n=503) saw complete clearance of AKs in the field of treatment compared with placebo (n=502). The most common adverse events were local skin reactions, including erythema, flaking/scaling, crusting, and swelling. Pain, pruritus, and infection at the application site, as well as periorbital edema and headache, were other adverse events that occurred in ≥2% of individuals treated with ingenol mebutate gel.

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Last modified: July 22, 2021