Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients

Phase 3

Terminated

Brief Summary: The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

Detailed Description: This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.

The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.

Recruitment & Eligibility

Inclusion Criteria

Out-Patients of either sex aged ≥ 40 years
Life-expectancy of 2 years at minimum
Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant
Patients treated for 5 years with an immunosuppressant medication
Severe sun damage of the skin
Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi
No present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed
Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH GCP

Exclusion Criteria

Non-Caucasian
Absence of sun damage i.e. no signs of AK
Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas)
Evidence of systemic infection, except viral hepatitis, at the time of recruitment
Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation
Patients participating in a clinical trial within the last four weeks before trial
Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation
Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or Cryotherapy for hyperkeratotic lesions are allowed)
Change of the immunosuppression-treatment less than 3 months ago or planned
Present or planned interferon therapy (in liver transplant patients with hepatitis B/C)
Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception

Arm && Interventions

Group	Intervention	Description
Standard Sun Protection Measures	Standard Sun Protection Measures	Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).
MD-3511356	MD-3511356	Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).

Primary Outcome Measures

Name	Time	Method
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas	2 Years

Secondary Outcome Measures

Name	Time	Method
Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas	2 Years

Locations (10): Charles University Hospital
🇨🇿
Plzen, Czech Republic
Hôpital Edouard
🇫🇷
Lyon, France
Medizinische Universität Wien
🇦🇹
Wien, Austria
Klinikum der Charité Universitätsmedizin
🇩🇪
Berlin, Germany
Leiden University Medical Center
🇳🇱
Leiden, Netherlands
Hautklinik am Nationalen Zentrum für Tumorerkrankungen
🇩🇪
Heidelberg, Germany
Başkent University Faculty of Medicine
🇹🇷
Ankara, Turkey
Beaumont Hospital
🇮🇪
Dublin, Ireland
Universitätsspital Zürich, Dermatologische Klinik
🇨🇭
Zürich, Switzerland
Queen Mary University of London
🇬🇧
London, United Kingdom