Actinic Keratoses Clinical Trial
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
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.
Status | Terminated |
Enrollment | 244 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Medizinische Universität Wien | Wien | |
Czech Republic | Charles University Hospital | Plzen | |
France | Hôpital Edouard | Lyon | |
Germany | Klinikum der Charité Universitätsmedizin | Berlin | |
Germany | Hautklinik am Nationalen Zentrum für Tumorerkrankungen | Heidelberg | |
Ireland | Beaumont Hospital | Dublin | |
Netherlands | Leiden University Medical Center | Leiden | |
Switzerland | Universitätsspital Zürich, Dermatologische Klinik | Zürich | |
Turkey | Baskent University Faculty of Medicine | Ankara | |
United Kingdom | Queen Mary University of London | London |
Lead Sponsor | Collaborator |
---|---|
Spirig Pharma Ltd. |
Austria, Czech Republic, France, Germany, Ireland, Netherlands, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas | 2 Years | No | |
Secondary | Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas | 2 Years | No |
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