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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532453
Recruitment Status : Terminated (For futility reasons and potential "loss of chance" for MD 3511356 group)
First Posted : February 14, 2012
Results First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Spirig Pharma Ltd.

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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Squamous Cell Carcinomas Device: MD-3511356 Other: Standard Sun Protection Measures Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : November 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard Sun Protection Measures
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
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

Experimental: MD-3511356
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
Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

Primary Outcome Measures :
  1. Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas [ Time Frame: 2 Years ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532453

Medizinische Universität Wien
Wien, Austria
Czech Republic
Charles University Hospital
Plzen, Czech Republic
Hôpital Edouard
Lyon, France
Klinikum der Charité Universitätsmedizin
Berlin, Germany, 10117
Hautklinik am Nationalen Zentrum für Tumorerkrankungen
Heidelberg, Germany
Beaumont Hospital
Dublin, Ireland
Leiden University Medical Center
Leiden, Netherlands
Universitätsspital Zürich, Dermatologische Klinik
Zürich, Switzerland
Başkent University Faculty of Medicine
Ankara, Turkey
United Kingdom
Queen Mary University of London
London, United Kingdom
Sponsors and Collaborators
Spirig Pharma Ltd.
Principal Investigator: Claas Ulrich, MD Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany

Responsible Party: Spirig Pharma Ltd. Identifier: NCT01532453     History of Changes
Other Study ID Numbers: SP 488/2009
First Posted: February 14, 2012    Key Record Dates
Results First Posted: January 8, 2016
Last Update Posted: January 8, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Keratosis, Actinic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Skin Diseases
Precancerous Conditions