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

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