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Optimization of photodynamic therapy for actinic keratoses with an aminolevulinic acid patch

Two separate multicenter, randomized, parallel-group, phase III studies were conducted to investigate the efficacy and safety of a self-adhesive patch containing 8 mg of 5-aminolevulinic acid (5-ALA) and photodynamic therapy (PDT) in treating actinic keratoses. One study had a superiority design, was observer blinded and randomized 103 patients to either 5-ALA/PDT or placebo/PDT treatments. The other study was a noninferiority, open design and randomized 346 patients to cryosurgery, placebo/PDT or 5-ALA/PDT. The primary outcome in both studies was the complete clinical clearance rate of lesions, 12 weeks post-PDT. Patient and investigator assessments were also made, with ratings from poor to excellent and not satisfied to very satisfied. Efficacy rates on a lesion ...