PD P 506 A or its placebo in combination with red light for photodynamic therapy of mild to moderate actinic keratosis

photonamic GmbH & Co. KG0 sites90 target enrollmentStarted: February 13, 2006Last updated: March 19, 2012

Conditions

Trial Snapshot

No summary available.

•- Written informed consent has been signed prior to or at Screening Visit
•- Caucasian male and female patients
•- Age > 18 years
•- Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on the head (hairless areas)
•- Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II): Mild grade (I): Flat, pink maculae or patch on sun-damaged skin, background mottling, no roughness or hyper-keratosis. Moderate grade (II): Pink to red papule or plaque with rough, hyperkeratotic surface, variable induration.
•- 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 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 (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, Aldara®, 5-FU or vitamin A acid containing formulations)
•- 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

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