Clinical trial NCT00308867: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: PDT
AK
Cryosurgery
Lead sponsor: photonamic GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-03-30
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
timeFrame: 12 weeks
Secondary outcomes:
measure: CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment
timeFrame: 12 months
measure: CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment
timeFrame: 12 months
measure: Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery)
timeFrame: 12 months
measure: Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion
timeFrame: 12 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
city: Berlin
country: Germany
facility: Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Praxis Dr. Simon
city: Biberach
country: Germany
facility: Gemeinschaftspraxis Dres. Steinert
city: Buxtehude
country: Germany
facility: Elbekliniken Dermatologisches Zentrum
city: Duelmen
country: Germany
facility: Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst
city: Frankfurt a.M.
country: Germany
facility: Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
city: Guetersloh
country: Germany
facility: Gemeinschaftspraxis Prof. Melnik, H. Hariry
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering
city: Kiel
country: Germany
facility: Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann
city: Kiel
country: Germany
facility: Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit
city: Kiel
country: Germany
facility: Tagesklinik für Allergie- u. Hautkrankheiten
city: Koblenz
country: Germany
facility: Praxis Dr. Habermann
city: Landau
country: Germany
facility: Praxis Dr. Fritz
city: Muenchen
country: Germany
facility: Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck
city: Noerdlingen
country: Germany
facility: Praxis Dr. Tanner
city: Pfungstadt
country: Germany
facility: Praxis Dr. Nickel
city: Pinneberg
country: Germany
facility: Praxis Dr. Itschert
city: Radolfzell
country: Germany
facility: Praxis Dr. Rozsondai
city: Rastatt
country: Germany
facility: Praxis Dr. Gehse
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie
city: Soest
country: Germany
facility: Praxis Dr. Karl
city: Tuebingen
country: Germany
facility: Praxis Dr. Datz
city: Vechta
country: Germany
facility: Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch
city: Westerland
country: Germany
facility: Praxis Dr. Imberger
city: Wuppertal
country: Germany
facility: Praxis PD Dr. Dirschka
Study officials:
affiliation: Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
name: Rolf-Marcus Szeimies, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: