E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal transplant male or female subjects, aged at least 18 years old, with history of immunosuppression from 5 to 15 years, and with a diagnosis of field actinic keratosis on face, scalp, forearms or chest (minimum of 4 discrete mild or moderate AKs) and meeting other specific inclusion/exclusion criteria. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
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 |
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix® Photodynamic therapy (PDT) of Actinic Keratoses (AK) and cancerised field in renal transplant recipients. It will be studied if Metvix® reduces the number of molecular aberrations leading to epidermal neoplasia in the treated area. Both the treatment effect [on existing lesions (actinic keratoses)] and the prophylactic effect (prevention of appearance of new lesions) will be measured and linked to the effect on gene expression. |
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E.2.2 | Secondary objectives of the trial |
In addition to the main objectif the Investigator will assess at each evaluation visit after baseline all clinical actinic keratosis lesions' response to the procedure, within the target field, as follows : clear or not completely clear lesion (including new and recurrent lesions). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Renal transplant male or female subject, aged at least 18 years old, with an history of immunosuppression from 5 to 15 years, - Subject presenting field of mild or moderate AKs with at least 4 discrete mild or moderate AK lesions on the face, scalp, forearms or chest , - Female of child-bearing potential with negative urinary pregnancy test at the beginning of the study and who practices a highly effective method of contraception all along the study and female of non childbearing potential, - Subject able to follow study instructions and likely to complete all required visits. |
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E.4 | Principal exclusion criteria |
- Female subject who is pregnant, or of child-bearing potential and wishing to become pregnant during the study, or is breast feeding, - Subject who is at risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®, - Subject with thick AK lesions on the target field, - Subjects with pigmented AK(s) on the target field, - Subject with AK lesions clinically atypical or suspicious for malignancy on the target field, - Subject presenting other skin lesions (including non melanoma skin cancers) on the target field, - Subject with suspected porphyria, - Subject with a bad skin condition (eczema, rosacea, acne, atopic dermatitis, psoriasis…) in the target field or who is 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, - Subject who has been treated in the target field with any of the following topical treatments within the specified washout period at Screening: . 5-FU, Imiquimod, Diclofenac sodium: 3 months . Cryotherapy: 3 months . PDT: 3 months . Other less common AK treatments: 3 months - Subject who has been treated with systemic retinoids within the last month prior to Screening visit, - Subject with known HIV or chronic hepatitis B and/or C (To be confirmed based on previous blood analysis done at a maximum within 3 months prior to the Screening visit or, if not available will be confirmed at Baseline with blood sample results performed at Screening), - Subject who has participated in another investigational drug or device research study within 30 days of enrolment (screening visit), - Subject requiring concurrent treatment that would interfere with study objectives and/or evaluations, - Adult protected by the law (adult under guardianship, or hospitalised in a public or private institution for a reason other than the study, or subject deprived of freedom), - Subject who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...). |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
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 | 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |