Spots Global Cancer Trial Database for PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK
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Trial Identification
Brief Title: PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK
Official Title: Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
Study ID: NCT00308867
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber, Augsburg, , Germany
Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin, Berlin, , Germany
Praxis Dr. Simon, Berlin, , Germany
Gemeinschaftspraxis Dres. Steinert, Biberach, , Germany
Elbekliniken Dermatologisches Zentrum, Buxtehude, , Germany
Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst, Duelmen, , Germany
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin, Frankfurt a.M., , Germany
Gemeinschaftspraxis Prof. Melnik, H. Hariry, Guetersloh, , Germany
Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering, Hildesheim, , Germany
Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann, Kiel, , Germany
Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit, Kiel, , Germany
Tagesklinik für Allergie- u. Hautkrankheiten, Kiel, , Germany
Praxis Dr. Habermann, Koblenz, , Germany
Praxis Dr. Fritz, Landau, , Germany
Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck, Muenchen, , Germany
Praxis Dr. Tanner, Noerdlingen, , Germany
Praxis Dr. Nickel, Pfungstadt, , Germany
Praxis Dr. Itschert, Pinneberg, , Germany
Praxis Dr. Rozsondai, Radolfzell, , Germany
Praxis Dr. Gehse, Rastatt, , Germany
Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie, Regensburg, , Germany
Praxis Dr. Karl, Soest, , Germany
Praxis Dr. Datz, Tuebingen, , Germany
Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch, Vechta, , Germany
Praxis Dr. Imberger, Westerland, , Germany
Praxis PD Dr. Dirschka, Wuppertal, , Germany
Contact Details
Name: Rolf-Marcus Szeimies, Professor MD
Affiliation: Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
Role: PRINCIPAL_INVESTIGATOR
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