E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with mild to moderate Actinic Keratoses on locations other than the face and scalp |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
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 |
Main objective of the study is to compare the efficacy and safety of Metvix® PDT cream with that of cryotherapy in subjects with Actinic Keratoses on locations other than the face and scalp, as measured by a lesion response assessment at week 24. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives is to show a non-inferiority of Metvix® PDT compared to cryotherapy in terms of lesion response. This will be measured by the lesion response assessment at week 12, and by the whole subject’s response at weeks 12 and 24. The difference as measured by cosmetic outcome at week 12 and 24 (as assessed by the investigator), and at week 24 (as assessed by the subject) will also be investigated. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Subjects with clinical diagnosis of mild or moderate non hyperkeratotic Actinic Keratoses on the locations other than the face /scalp (including ears): (aim of the study is to only enrol subjects with AKs) -Subjects with AKs on locations other that the face/scalp with at least 4 comparable symmetrical and bilateral lesions (i.e.on the same body zone) (at least 2 lesions on each side of the body),of similar severity and similar number with no more than a twofold difference between the two sides (this ensures an equal comparator and minimises outcome bias). -Males or female subjects older than 18 years: (there is no experience to date in treating patients below the age of 18 with Metvix PDT). -Female subjects of childbearing potential must have a negative pregnancy test at the beginning of the study, unless a female of proven non-childbearing potential, e.g.: menopausal. (There is no clinical data on Metvix use in pregnant patients therefore Metvix is not recommended during pregnancy). -Subjects must sign the Informed Consent form prior to any study procedure
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E.4 | Principal exclusion criteria |
- Female subjects who are pregnant, nursing or planning a pregnancy during the study: (Rationale as above). - Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the subject at risk, may confound the study results, or may interfere with the Subject's participation in the study (This is to safeguard subject's safety as the correct clinical care of the subject is always the main concern. It also limits the inclusion of a heterogeneous population into the study). - Subjects with known allergy to methyl aminolevulinate, to a similar compound or to any ingredient of the cream (Subject's safety criteria). - Subjects with a wash-out period for relevant topical treatment on the treated area of less than 3 months according to the protocol ( Subject's safety criteria). - Subjects with more than 10 AK lesions on each treated zone (any more than 10 AKs per treated zone would be difficult to assess by the investigator and enable meaningful statistical analysis).
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E.5 End points |
E.5.1 | Primary end point(s) |
Lesion response rate at week 24 visit (clinically assessed) |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The end of the trial is when the last subject has completed the last visit of the study (week 24 visit) |
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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 | 0 |
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 | 0 |