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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Actinic Keratoses, Squamous Cell Carcinomas

Intervention / Treatment
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* Device: MD-3511356
* Other: Standard Sun Protection Measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Sun Protection Measures<br>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). | Other: Standard Sun Protection Measures<br>* Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.<br>|
| Experimental: MD-3511356<br>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). | Device: MD-3511356<br>* Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas |  | 2 Years |