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

Sponsored by:	photonamic GmbH & Co. KG
Information provided by:	photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00308867

Purpose

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.

Condition	Intervention	Phase
Actinic Keratosis	Procedure: Photodynamic Therapy Procedure: Cryosurgery	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis

Further study details as provided by photonamic GmbH & Co. KG:

Primary Outcome Measures:

Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

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 ]

Enrollment:	349
Study Start Date:	March 2006
Study Completion Date:	November 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308867

Locations

Germany
Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch
Vechta, Germany, 49377
Tagesklinik für Allergie- u. Hautkrankheiten
Kiel, Germany, 24148
Praxis Dr. Datz
Tuebingen, Germany, 72072
Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann
Kiel, Germany, 24103
Praxis PD Dr. Dirschka
Wuppertal, Germany, 42275
Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst
Duelmen, Germany, 48249
Praxis Dr. Fritz
Landau, Germany, 76829
Praxis Dr. Gehse
Rastatt, Germany, 76437
Praxis Dr. Habermann
Koblenz, Germany, 56068
Praxis Dr. Imberger
Westerland, Germany, 25980
Praxis Dr. Itschert
Pinneberg, Germany, 25421
Praxis Dr. Karl
Soest, Germany, 59494
Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie
Regensburg, Germany, 93053
Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck
Muenchen, Germany, 81545
Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit
Kiel, Germany, 24103
Gemeinschaftspraxis Prof. Melnik, H. Hariry
Guetersloh, Germany, 33330
Elbekliniken Dermatologisches Zentrum
Buxtehude, Germany, 21614
Praxis Dr. Nickel
Pfungstadt, Germany, 64319
Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering
Hildesheim, Germany, 31134
Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
Augsburg, Germany, 86179
Gemeinschaftspraxis Dres. Steinert
Biberach, Germany, 88400
Praxis Dr. Simon
Berlin, Germany, 10827
Praxis Dr. Rozsondai
Radolfzell, Germany, 78315
Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
Berlin, Germany, 10117
Praxis Dr. Tanner
Noerdlingen, Germany, 86720
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., Germany, 60590

Sponsors and Collaborators

photonamic GmbH & Co. KG

Investigators

Principal Investigator:

Rolf-Marcus Szeimies, Professor MD

Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie

More Information

Study ID Numbers:	AK 04, EudraCT No. 2005-003556-36
Study First Received:	March 29, 2006
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00308867
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by photonamic GmbH & Co. KG:

PDT
AK
Cryosurgery

Study placed in the following topic categories:

Keratosis
Skin Diseases
Tylosis

ClinicalTrials.gov processed this record on January 14, 2009