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

Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations

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.

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.

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