PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK

NCT ID: NCT00308867

Last Updated: 2008-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-11-30

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.

Conditions

Actinic Keratosis

Keywords

PDT; AK; Cryosurgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Photodynamic Therapy

Intervention Type: PROCEDURE

Cryosurgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Caucasians
• Age > 18 years
• Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on head and/or face (hairless areas)
• Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II)
• The distance between the study lesion borders is > 1.0 cm
• Maximum diameter of each study lesion is 1.8 cm
• Skin sun sensitivity type I to IV according to Fitzpatrick

Exclusion Criteria

• PDT Non-responder
• Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding study treatment
• Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
• Pre-treatment with hypericin during the 2 weeks preceding study therapy
• Treatment with systemic retinoids during the 3 months preceding study therapy
• Treatment with cytostatics or radiation during the 3 months preceding study therapy
• Female patients of childbearing potential
• Patients with clinically relevant suppression of the immune system
• Diagnosis of Porphyria
• Skin diseases that might interfere with response evaluation of study treatment
• Skin sun sensitivity type V or VI according to Fitzpatrick
• Known intolerance to one or more of the ingredients of the study medication
• Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance)
• Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
• Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
• Suspected lack of compliance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

photonamic GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Rolf-Marcus Szeimies, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie

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

Dülmen, , Germany

Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin

Frankfurt a.M., , Germany

Gemeinschaftspraxis Prof. Melnik, H. Hariry

Gütersloh, , 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

München, , Germany

Praxis Dr. Tanner

Nördlingen, , 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

Tübingen, , Germany

Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch

Vechta, , Germany

Praxis Dr. Imberger

Westerland, , Germany

Praxis PD Dr. Dirschka

Wuppertal, , Germany

Countries

Germany

Other Identifiers

EudraCT No. 2005-003556-36

Identifier Type: -

Identifier Source: secondary_id

AK 04

Identifier Type: -

Identifier Source: org_study_id