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

Actinic Keratosis Clinical Trial

Official title:

Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308867
• Other study ID #: AK 04
• Secondary ID: EudraCT No. 2005
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2006
• Last updated: April 10, 2008
• Start date: March 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2008
• Source: photonamic GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: November 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Procedure:
• Photodynamic Therapy

• Cryosurgery

Locations

Country	Name	City	State
Germany	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	Duelmen
Germany	Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin	Frankfurt a.M.
Germany	Gemeinschaftspraxis Prof. Melnik, H. Hariry	Guetersloh
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	Muenchen
Germany	Praxis Dr. Tanner	Noerdlingen
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	Tuebingen
Germany	Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch	Vechta
Germany	Praxis Dr. Imberger	Westerland
Germany	Praxis PD Dr. Dirschka	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
photonamic GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.		12 weeks
Secondary	CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment		12 months
Secondary	CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment		12 months
Secondary	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
Secondary	Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion		12 months