An open, multicentre, randomised, inter-individual comparative, prospective clinical trial with MD-3511356 versus standard sun protection measures in immunosuppressed outpatients after solid organ transplantations for the prevention of UV-induced infections and carcinogenic skin alterations - Sunscreen to prevent skin cancer

Spirig Pharma AG0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月6日

适应症

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•Patients must meet all of the following criteria in order to be eligible for entry into the trial:
•1. Out-Patients of either sex aged >= 40 years
•2. Life-expectancy of 2 years at minimum
•3. Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant
•4. Patients treated for 5 years with an immunosuppressant medication
•5. Severe sun damage of the skin
•6. Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi
•7. No present squamous cell carcinoma, basal cell carcinoma or malignant melano-ma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed
•8. Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH-GCP

•Patients must not be enrolled in the trial if any of the following criteria is met:
•1. Non-Caucasian
•2. Absence of sun damage i.e. no signs of AK
•3. Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas)
•4. Evidence of systemic infection, except viral hepatitis, at the time of recruitment
•5. Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation
•6. Patients participating in a clinical trial within the last four weeks before trial
•7. Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation
•8. Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or kryotherapy for hyperkeratotic lesions are allowed)
•9. Change of the immunosuppression-treatment less than 3 months ago or planned
•10. Present or planned interferon therapy (in liver transplant patients with hepatitis B/C)
•11. Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception

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