Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
Condition: Actinic Keratoses; Squamous Cell Carcinomas
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: MD-3511356; Standard Sun Protection Measures
Intervention description: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.; Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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