Ingenol mebutate gel (Picato): A topical gel for the treatment of actinic keratosis
On January 25, 2012, FDA approved ingenol mebutate (Picato) gel as a topical treatment of actinic keratosis. The mechanism of action by which ingenol mebutate gel induces cell death in actinic keratosis lesions is not known.
Efficacy. Ingenol mebutate's efficacy was established in 4 randomized, vehicle-controlled clinical studies. The primary efficacy end point was complete and partial (≥75% reduction in lesions) clearance of actinic keratosis lesions within the treatment area at 8 weeks. Studies 1 and 2 (n=547) assessed efficacy of ingenol mebutate applied to the face and scalp, while studies 3 and 4 (n=458) evaluated its efficacy when applied to the trunk and extremities. Complete clearance occurred more commonly in the ingenol mebutate group compared to control in studies 1 to 4 (37% vs 2%, 47% vs 5%, 28% vs 5%, and 42% vs 5%, respectively). Similarly, partial clearance occurred more commonly in the ingenol mebutate group compared to control in studies 1 to 4 (60% vs 7%, 68% vs 8%, 44% vs 7%, and 55% vs 7%, respectively). Recurrence rates after 12 months following treatment ranged between 50% and 54%.
Safety. The safety of ingenol mebutate was evaluated in 2 clinical studies (n=499) in subjects with actinic keratosis. The most common adverse reactions (occurring in ≥2%) were local skin reactions (including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ ulceration), application-site pain, pruritus, irritation, and infection, periorbital edema, nasopharyngitis, and headache. Eye disorders such as severe eye pain, eyelid edema, eyelid ptosis, and periorbital edema also occurred, but less frequently.
Dosing. Ingenol mebutate gel (0.015%) should be applied once daily for 3 consecutive days to the face or scalp. For lesions on the trunk or extremities, ingenol mebutate gel (0.05%) should be administered for 2 consecutive days. The treatment area should not exceed 25 cm2. Treatment should be applied evenly to the lesion site and allowed to dry for 15 minutes. The application site should remain untouched for a period of 6 hours, but may subsequently be washed with mild soap after this time. Ingenol mebutate should not be applied to damaged skin. Patients should be instructed to wash hands after each application.
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