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Topical ingenol mebutate gel for the treatment of superficial basal cell carcinoma

A randomized, multicenter, vehicle-controlled phase IIa study evaluated the safety of two applications of ingenol mebutate gel (PEP-005) for the topical treatment of superficial basal cell carcinoma (sBCC). Sixty patients with sBCC were randomized to treatment on days 1 and 2 (arm A; n = 30) or days 1 and 8 (arm B; n = 30) and within each arm to PEP-005 0.0025, 0.01 or 0.05% or vehicle gel. The main outcome measure was the incidence and severity of adverse events and local skin responses in arms A and B. Lesion clearance at day 85 was a secondary measure. The overall incidence of adverse events was low; one patient in ...