E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from actinic keratosis to be treated with PDT |
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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 |
Effect of IDEA-070 compared to placebo on pain and inflammation induced by PDT |
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E.2.2 | Secondary objectives of the trial |
Clearance rate Safety of IDEA-070 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Diagnosis of actinic keratosis to be treated with PDT - affecting equal sized areas of both sides of the head - affecting at least 10% of the area of photo-exposure Aged 18-85 years Reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intraueterine-devices, sexual abstinence or vasectomised partner) Willing to obstain from excessive sun/UV exposure during the course of the study |
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E.4 | Principal exclusion criteria |
Other clinically relevant dermal or systemic diseases including malignancy Major hypertrophy of lesions Porphyria Topical treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 months prior to screening Immunosuppressants within 2 weeks prior to screening Concomitant use of topical immunmodulators, other analgesics including topical NSAIDs, retinoids, antioxidants Known sensitisation to NSAIDs Photoallergy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Endpoints related to and including the primary efficacy endpoints are: -Patient evaluation of pain using a 100 mm VAS, rated 3.0-3.5 h before PDT, immediately after PDT, 4 h after PDT (day 1), 24 h after PDT (day 2), on day 4, day 8, and day 28 -Investigator evaluation of inflammation using an aggregate (sum) score and corresponding subscores, evaluated 3.0-3.5 h before PDT, 4 h after PDT (day 1), 24 h after PDT (day 2), on day 4, day 8, and day 28 -The change of pain VAS from 3.0-3.5 hours prior to PDT, i.e. the difference “assessment value” – “3.0-3.5 hours prior to PDT”; primary efficacy endpoint for “assessment value” = “immediately post PDT until 24 h post PDT” -The change of aggregate (sum) score of inflammation from 3.0-3.5 hours prior to PDT, i.e. the difference “assessment value” – “3.0-3.5 hours prior to PDT”; primary efficacy endpoint for “assessment value” = “4 h post PDT until day 8”
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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 | No |
E.6.4 | Safety | Yes |
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) | 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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |