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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308867
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : April 11, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Procedure: Photodynamic Therapy Procedure: Cryosurgery Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2007

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

Secondary Outcome Measures :
  1. CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment [ Time Frame: 12 months ]
  2. CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment [ Time Frame: 12 months ]
  3. 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 ]
  4. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308867

Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
Augsburg, Germany, 86179
Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
Berlin, Germany, 10117
Praxis Dr. Simon
Berlin, Germany, 10827
Gemeinschaftspraxis Dres. Steinert
Biberach, Germany, 88400
Elbekliniken Dermatologisches Zentrum
Buxtehude, Germany, 21614
Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst
Duelmen, Germany, 48249
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., Germany, 60590
Gemeinschaftspraxis Prof. Melnik, H. Hariry
Guetersloh, Germany, 33330
Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering
Hildesheim, Germany, 31134
Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann
Kiel, Germany, 24103
Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit
Kiel, Germany, 24103
Tagesklinik für Allergie- u. Hautkrankheiten
Kiel, Germany, 24148
Praxis Dr. Habermann
Koblenz, Germany, 56068
Praxis Dr. Fritz
Landau, Germany, 76829
Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck
Muenchen, Germany, 81545
Praxis Dr. Tanner
Noerdlingen, Germany, 86720
Praxis Dr. Nickel
Pfungstadt, Germany, 64319
Praxis Dr. Itschert
Pinneberg, Germany, 25421
Praxis Dr. Rozsondai
Radolfzell, Germany, 78315
Praxis Dr. Gehse
Rastatt, Germany, 76437
Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie
Regensburg, Germany, 93053
Praxis Dr. Karl
Soest, Germany, 59494
Praxis Dr. Datz
Tuebingen, Germany, 72072
Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch
Vechta, Germany, 49377
Praxis Dr. Imberger
Westerland, Germany, 25980
Praxis PD Dr. Dirschka
Wuppertal, Germany, 42275
Sponsors and Collaborators
photonamic GmbH & Co. KG
Principal Investigator: Rolf-Marcus Szeimies, Professor MD Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie Identifier: NCT00308867     History of Changes
Other Study ID Numbers: AK 04
EudraCT No. 2005-003556-36
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008

Keywords provided by photonamic GmbH & Co. KG:

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions