The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.
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 double-blind manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
349
Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
Augsburg, Germany
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
Time frame: 12 weeks
CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment
Time frame: 12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment
Time frame: 12 months
Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery)
Time frame: 12 months
Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion
Time frame: 12 months
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Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
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Gemeinschaftspraxis Prof. Melnik, H. Hariry
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...and 16 more locations