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

Phase 3

Completed

• Conditions: Actinic Keratosis

• Registration Number: NCT00308867
• Lead Sponsor: photonamic GmbH & Co. KG

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-03-30
• Primary Completion: 2007-06
• Study Completion: 2007-11
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-10
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.	12 weeks

Secondary Outcome Measures

Name	Time	Method
CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment	12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment	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)	12 months
Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion	12 months

Trial Locations

Locations (26)

Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst; 🇩🇪 Duelmen, Germany

Praxis Dr. Simon; 🇩🇪 Berlin, Germany

Gemeinschaftspraxis Dres. Steinert; 🇩🇪 Biberach, Germany

Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber; 🇩🇪 Augsburg, Germany

Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin; 🇩🇪 Frankfurt a.M., Germany

Praxis Dr. Tanner; 🇩🇪 Noerdlingen, Germany

Praxis Dr. Rozsondai; 🇩🇪 Radolfzell, Germany

Praxis Dr. Karl; 🇩🇪 Soest, Germany

Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann; 🇩🇪 Kiel, Germany

Elbekliniken Dermatologisches Zentrum; 🇩🇪 Buxtehude, Germany

Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit; 🇩🇪 Kiel, Germany

Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering; 🇩🇪 Hildesheim, Germany

Tagesklinik für Allergie- u. Hautkrankheiten; 🇩🇪 Kiel, Germany

Praxis Dr. Nickel; 🇩🇪 Pfungstadt, Germany

Praxis Dr. Itschert; 🇩🇪 Pinneberg, Germany

Praxis Dr. Imberger; 🇩🇪 Westerland, Germany

Gemeinschaftspraxis Prof. Melnik, H. Hariry; 🇩🇪 Guetersloh, Germany

Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Praxis Dr. Fritz; 🇩🇪 Landau, Germany

Praxis Dr. Habermann; 🇩🇪 Koblenz, Germany

Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck; 🇩🇪 Muenchen, Germany

Praxis Dr. Gehse; 🇩🇪 Rastatt, Germany

Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie; 🇩🇪 Regensburg, Germany

Praxis Dr. Datz; 🇩🇪 Tuebingen, Germany

Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch; 🇩🇪 Vechta, Germany

Praxis PD Dr. Dirschka; 🇩🇪 Wuppertal, Germany