E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Comparison of the efficacy of PD P 506 A photodynamic therapy (PD P 506 A-PDT) with placebo-PDT (PD P 506 P-PDT) for the treatment of mild to moderate actinic keratoses located on head and face 12 weeks after PDT on lesion basis. |
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E.2.2 | Secondary objectives of the trial |
- Comparison of the efficacy of PD P 506 A-PDT with placebo-PDT on patient basis 12 weeks after PDT. - Comparison of the efficacy of PD P 506 A-PDT with placebo-PDT on lesion and patient basis 6, 9 and 12 months after PDT. - Comparison of safety and tolerability of (a) application of study medications and (b) PD P 506 A-PDT and placebo-PDT. - Cosmetic outcome 3, 6, 9 and 12 months after PDT in case of no recurrence of the lesion.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- 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
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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 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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E.5 End points |
E.5.1 | Primary end point(s) |
Complete clinical clearance rate of treated actinic keratosis lesions 12 weeks after PDT |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
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 |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |