PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy 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). A direct comparison versus placebo which is necessary for the
exact quantification of the effect of PD P 506 A has not yet been performed and is subject
of this study protocol.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT
Axel Hauschild, Professor MD
Christian-Albrechts-Universität zu Kiel, Germany
Germany: Federal Institute for Drugs and Medical Devices