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.
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 kryotherapy 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