An open-label, randomized, parallel-group, multicenter study assessed the effects of methyl aminolevulinate (MAL) incubation at 80 or 160 mg/g for 1 or 3 hours with photodynamic therapy (PDT) of actinic keratoses (AK) in 112 patients. Patients were treated with MAL cream for 1 or 3 hours and PDT (570-670 nm; light dose 75 J/cm2). The main outcome was lesion response at 3 and 12 months post-treatment. Overall complete response (CR) rates ranged from 78-88% for 1-hour and 82-87% for 3-hour MAL-PDT therapy using the 160 mg/g MAL. For MAL 80 mg/g, CR ranged from 46-85% and 27-87% with 1- and 3-hour incubations, respectively. Lesion recurrence rates were lower with the 160 ...