E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
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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 |
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E.2.2 | Secondary objectives of the trial |
tolerability, PGA, patient assessment & compliance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· All of the following criteria have to be met for inclusion of a subject in the study: • male or female aged 18 + years; • clinical assessment of max 5 actinic keratoses on face, scalp and/ or hands • mild to moderate actinic keratosis lesions (AK I + II) up to 1,5 cm in diameter • minimal distance between lesions of 1,5 cm • physical examination without further disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • skin type I – IV (Fitzpatrick) • women with childbearing potential must use a reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) like implants, injectables, combines oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner • pregnancy test negative (in women with childbearing potential) • physical ability to apply the product correctly • written informed consent obtained.
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E.4 | Principal exclusion criteria |
· Subjects are to be excluded from the study when one or more of the following conditions are met: • Acute or pre-existing Basal cell carcinoma, BCC or Squamous cell carcinoma, SCC • Treatment with topical treatment (e.g. Diclofenac/ Solaraze®) within the past 4 weeks • Treatment with PDT within the past 3 month • Indication to perform a biopsy for histological diagnostic • „Cornu cutaneum“-like phenomena in treatment area • Non-responder to previous 5-FU treatment • Erosion or ulcera in the application area • Acute skin inflammation in the target area • Indication for immunosuppressive drugs (e.g. Methotrexat, Sulfonylharnstoff) • Indication for treatment with Brivudin (Zostex®) within the past 4 weeks (interaction with 5-FU) • Known lack of Dihydropyrimidine dehydrogenase (DPD) activity • Indication for treatment with Phenytoin (Phenhydan®, Phenytoin-AWD®, Zentropil®) within the past 4 weeks (interaction with 5-FU) • Pregnancy or breastfeeding • Known renal insufficiency • evidence of drug or alcohol abuse; • symptoms of another clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in another clinical study in the 4 weeks preceding the study; • known allergic reactions to components of the study preparations • treatment with systemic or locally acting medications which might counter or influence the study aim • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to understand the study and give adequately informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
improvement in clinical score |
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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 | 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 | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |