Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy


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FDAlogoThe FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive days. Ingenol mebutate gel is the first topical actinic keratosis therapy that can be used for as little as 2 or 3 days.

Studies show that about 65% of squamous cell carcinomas begin as untreated actinic keratosis, and guidelines from the American Academy of Dermatology estimate that 60% of predisposed persons older than 40 have at least one actinic keratosis.

In four phase III studies of more than 1,000 patients, a significantly higher proportion of those treated with ingenol mebutate gel (n = 503) saw complete clearance of actinic keratoses in the field of treatment, compared to placebo. ■



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