E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with actinic keratoses (AK) |
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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 |
Primary objective of the trial is to assess the efficacy of diclofenac sodium 3% administered topically in patients with actinic keratoses (AK). |
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E.2.2 | Secondary objectives of the trial |
Primary objective of the trial is to assess the safety of diclofenac sodium 3% administered topically in patients with actinic keratoses (AK). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who are able to read and comprehend the informed consent form 2. Patients who have signed the informed consent form 3. Patients with visible and histologically (> 20% of patients) proven actinic keratosis, who have a clinical diagnosis of AKs in at least one of the selected major body areas (forehead, central face, scalp, dorsa of hands) 4. External (ambulatory) patients, of both sexes, of ages between 35 and 75 inclusively 5. Patients who, in the investigator’s opinion, are otherwise healthy based on physical examination, medical history, and vital signs 6. Patients who are willing and able to attend study appointments within allowed time limits
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E.4 | Principal exclusion criteria |
1. Patients who have participated earlier (< 1 month) in another clinical trial
2- Patients who are taking prohibited recent or synchronious pharmaceutical prescription, meaning: imiquimod or 5-FU, etretinate, cyclosporine, retinoids, topical steroids or recent trichloroacetic acid or glycolic acid peels) in the time span of last one month before the start of the trial.
3- Patients with clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal endocrine or gastrointestinal abnormalities or diseases.
4- Any dermatological disease and/or condition in the treatment or surrounding area (3cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination.
5. Patients with lesions on the lips
6 Female patients who are pregnant or are lactating.
7.Female patients with the ability to procreate and who are not using adequate contraception
8.Patients with known allergies to any excipient in the study drug
9. Patients who have a known sensitivity reaction like asthma, pruritus or allergic rhinitis following treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatoty drugs (NSAIDs).
10. Patients who, in the investigator’s opinion, are unlikely to comply with the clinical study protocol , or who are not appropriate for any other reasons
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E.5 End points |
E.5.1 | Primary end point(s) |
• Change in the TLNS (Target Lesion Number Score).
• Change in the CLNS (Cumulative Lesion Number Score).
• Change in the IGII (Investigator Global Improvement Index).
• Change in the PGII (Patient Global Improvement Index).
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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 | 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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |