Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK

photonamic

Status and phase

Completed

Phase 3

Conditions

Actinic Keratosis

Treatments

Procedure: Photodynamic Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00308854

AK 03

EudraCT Number 2005-003555-13

Details and patient eligibility

About

The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.

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). A direct comparison versus placebo which is necessary for the exact quantification of the effect of PD P 506 A has not yet been performed and is subject of this study protocol.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent
Caucasian patients
Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on head and/or face (hairless areas)
Selected AK study lesions have clearly defined margins and are mild to moderate
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 PDT
Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
Pre-treatment with hypericin during the 2 weeks preceding PDT
Treatment with systemic retinoids during the 3 months preceding PDT
Treatment with cytostatics or radiation during the 3 months preceding PDT
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 PDT
Skin sun sensitivity type V or VI according to Fitzpatrick
Known intolerance to one or more of the ingredients of the study medication
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