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

This study has been terminated.
(For futility reasons and potential "loss of chance" for MD 3511356 group)
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01532453
First received: February 9, 2012
Last updated: December 3, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Actinic Keratoses
Squamous Cell Carcinomas
Device: MD-3511356
Other: Standard Sun Protection Measures
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spirig Pharma Ltd.:

Primary Outcome Measures:
  • Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: November 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532453

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

Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01532453     History of Changes
Other Study ID Numbers: SP 488/2009 
Study First Received: February 9, 2012
Results First Received: July 16, 2015
Last Updated: December 3, 2015
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Ireland: Irish Medicines Board
Ireland: Medical Ethics Research Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Institute for Health Research
Turkey: Ethics Committee
Turkey: Ministry of Health
Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
Netherlands: Dutch Health Care Inspectorate
Netherlands: Independent Ethics Committee

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

ClinicalTrials.gov processed this record on August 23, 2016