Clinical trial NCT01532453: Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Actinic Keratoses
Squamous Cell Carcinomas
Lead sponsor: Spirig Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 244
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
timeFrame: 2 Years
Secondary outcomes:
measure: Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas
timeFrame: 2 Years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Plzen
country: Czech Republic
facility: Charles University Hospital
city: Lyon
country: France
facility: Hôpital Edouard
city: Berlin
country: Germany
facility: Klinikum der Charité Universitätsmedizin
city: Heidelberg
country: Germany
facility: Hautklinik am Nationalen Zentrum für Tumorerkrankungen
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich, Dermatologische Klinik
city: Ankara
country: Turkey
facility: Başkent University Faculty of Medicine
city: London
country: United Kingdom
facility: Queen Mary University of London
Study officials:
affiliation: Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany
name: Claas Ulrich, MD
role: PRINCIPAL_INVESTIGATOR
References: