E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
- 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.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical complete clearance rate of treated actinic keratosis lesions at week 8 after therapy |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
different application durations of the IMP |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |