Gene expression in renal transplant patients with field Actinic Keratosis undergoing Metvix® PDT - Metvix® PDT
- Conditions
- 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
- Registration Number
- EUCTR2008-001603-30-GB
- Lead Sponsor
- Galderma R&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
- 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
- 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...).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method