Actinic keratosis
Conditions
Sponsors
photonamic GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent has been signed and dated - Caucasian male and female patients - Age > 18 years - Diagnosis of actinic keratosis (AK) which has been proven histologically in the patient’s history with at least three locally separated lesions located on the head (hairless areas) including the face -Selected AK study lesions are mild to moderate (grade I - 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
Exclusion criteria
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 the study (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, 5-FU or vitamin A acid containing formulations) - Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding the study with keratolytic agents e.g. urea or salicylic acid containing formulations - Treatment with systemic retinoids during the 3 months preceding the study - Use of photosensitising drugs e.g. tetracycline within a time frame where photosensitisation from these drugs may still be present - Female patients of childbearing potential - Diagnosis of Porphyria - Known or suspect acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 1.5 times the upper normal limit) - Manifest renal diseases with renal dysfunction - Known suppression of the immune system caused either virally or pharmacologically - Condition after organ transplantation - Any major concomitant disease - Psoriasis on the head - Skin diseases that might interfere with response evaluation of PD P 506 A-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 - Relationship of dependence between patient and sponsor or patient and investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the optimal application duration (0.5, 1, 2 or 4 h) of PD P 506 A at fixed light dosage (37 J/cm²) and wavelength (630 +/- 3 nm) for the photodynamic therapy of mild to moderate actinic keratoses located on the head (hairless areas) including face.;Secondary Objective: - Assessment of the safety of photodynamic therapy of actinic keratosis with PD P 506 A (PD P 506 A-PDT ). - Assessment of the safety of PD P 506 A application. - Assessment of the efficacy of PD P 506 A-PDT on a lesion basis at week 4 (visit 5). - Assessment of the efficacy of PD P 506 A-PDT on a patient basis at weeks 4 and 8 after therapy. ;Primary end point(s): Clinical complete clearance rate of treated actinic keratosis lesions at week 8 after therapy | — |
Countries
Germany
Outcome results
None listed