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

photonamic

Status and phase

Completed

Phase 3

Conditions

Actinic Keratosis

Treatments

Procedure: Cryosurgery

Procedure: Photodynamic Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00308867

EudraCT No. 2005-003556-36

AK 04

Details and patient eligibility

About

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.

Full 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.

Enrollment

349 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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