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

December 3, 2015 updated by: Spirig Pharma Ltd.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

244

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Medizinische Universitat Wien
  • Czech Republic
      • Plzen, Czech Republic
        • Charles University Hospital
  • France
      • Lyon, France
        • Hôpital Edouard
  • Germany
      • Berlin, Germany, 10117
        • Klinikum der Charité Universitätsmedizin
      • Heidelberg, Germany
        • Hautklinik am Nationalen Zentrum für Tumorerkrankungen
  • Ireland
      • Dublin, Ireland
        • Beaumont Hospital
  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center
  • Switzerland
      • Zürich, Switzerland
        • Universitätsspital Zürich, Dermatologische Klinik
  • Turkey
      • Ankara, Turkey
        • Başkent University Faculty of Medicine
  • United Kingdom
      • London, United Kingdom
        • Queen Mary University of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spirig Pharma Ltd.

Investigators

  • Principal Investigator: Claas Ulrich, MD, Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP 488/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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