Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure.
Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly
occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK
when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents
or photodynamic therapy (PDT). In Europe, cryosurgery is the method primarily used and will
therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be
necessary to validate the test system. While the comparison of PD P 506 A-PDT and
cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
Rolf-Marcus Szeimies, Professor MD
Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
Germany: Federal Institute for Drugs and Medical Devices