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. MedDRA version: 9.1 Level: LLT Classification code 10000614 Term: Actinic keratosis
Conditions
Interventions
Trade Name: Metvix® 160 mg/g cream
Product Name: Metvix 160 mg/g cream
Product Code: P 1202
Pharmaceutical Form: Cream
Sponsors
Galderma R&D
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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...).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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).;Primary end point(s): Week 18 | — |
Countries
United Kingdom
Outcome results
None listed