E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aktinic Keratosis Stage II and III. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000614 |
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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 |
To evaluate the effectiveness of different doses of HDP 99.0006 on actinic keratosis |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerance of 3 cycles of different doses of HDP 99.0006
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Actinic Keratosis stage II (hyperkeratotic epidermal lesions on skin overexposed to the sun), confirmed by biopsy. - Actinic Keratosis stage III (severe hyperkeratotic epidermal lesions on skin overexposed to the sun), confirmed by biopsy. - 10 or more lesions. The lesions should be located in the face, the balding scalp, the dorsal forearm or the back of the hands - Male or non-lactating, non-pregnant females. Female patients of childbearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for four weeks prior to receiving the first dose of study medication and six months after the last study dose is administered. Male patients with a female partner of childbearing potential should use a form of contraception as approved by the Investigator during the study and for six months after the last study dose is administered - 55 years of age or older - Ability to co-operate with treatment - Signed informed consent prior to start of any study specific procedures |
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E.4 | Principal exclusion criteria |
- Concomitant severe diseases or diseases which are contraindications for the use of Fluorouracil - Using any immunmodulaters, cytotoxic drugs or investigational drugs 4 weeks before Visit 2 - Confirmed or suspected bacterial or viral infection less than 3 weeks before Visit 2· - Diagnosed as having hematologic, hepatic or gastroinestinal abnormalities or diseases - No adequate hepatic function (bilirubin > 1.5 x UNL or alkaline phosphatase or transaminases > 2.5 x UNL) - No adequate renal function (serum creatinine > 1.5 x UNL)· Clinical evidence for HBV or HCV infection |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is the percentage change in the number of AK lesions at visit 15, compared to baseline. |
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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 | 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 | 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 |
2 steps: 1) Placebo vers. 50 vers. 100mg then safety evaluation, if favorable 2) placebo vers. 150mg |
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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
|
See Protocol Chapter 11 and 12 |
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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 | 24 |
E.8.9.1 | In the Member State concerned days | |