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Photodynamic therapy with a nanoemulsion-based aminolevulinic acid formulation to treat actinic keratosis: A controlled study

A prospective, randomized, double-blind, placebo-controlled phase III study compared the efficacy and safety of a stable nanoemulsion-based aminolevulinic acid (BF-200) with placebo in the photodynamic (PDT) treatment of 122 patients with mild-moderate actinic keratosis (AK) lesions. Patients were randomized to PDT + aminolevulinic acid (n = 81) or PDT + placebo (n = 41). The efficacy of aminolevulinic acid after 1 and 2 PDT treatments was evaluated 12 weeks after the last treatment. Two different light sources were used, the Aktilite® CL128 and the Photodyn® 750. The former was used in 4 centers in approximately 40% of each group. The latter source was used in another 4 centers in approximately 60% ...