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

Primary Purpose

Actinic Keratoses, Squamous Cell Carcinomas

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MD-3511356
Standard Sun Protection Measures
Sponsored by
Spirig Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Actinic Keratoses

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Universität Wien
  • Charles University Hospital
  • Hôpital Edouard
  • Klinikum der Charité Universitätsmedizin
  • Hautklinik am Nationalen Zentrum für Tumorerkrankungen
  • Beaumont Hospital
  • Leiden University Medical Center
  • Universitätsspital Zürich, Dermatologische Klinik
  • Başkent University Faculty of Medicine
  • Queen Mary University of London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Sun Protection Measures

MD-3511356

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas

Secondary Outcome Measures

Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas

Full Information

First Posted
February 9, 2012
Last Updated
December 3, 2015
Sponsor
Spirig Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01532453
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
For futility reasons and potential "loss of chance" for MD 3511356 group
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spirig Pharma Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses, Squamous Cell Carcinomas

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Sun Protection Measures
Arm Type
Active Comparator
Arm Description
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).
Arm Title
MD-3511356
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
MD-3511356
Intervention Description
Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
Intervention Type
Other
Intervention Name(s)
Standard Sun Protection Measures
Intervention Description
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
Primary Outcome Measure Information:
Title
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claas Ulrich, MD
Organizational Affiliation
Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Wien
City
Wien
Country
Austria
Facility Name
Charles University Hospital
City
Plzen
Country
Czech Republic
Facility Name
Hôpital Edouard
City
Lyon
Country
France
Facility Name
Klinikum der Charité Universitätsmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Hautklinik am Nationalen Zentrum für Tumorerkrankungen
City
Heidelberg
Country
Germany
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Universitätsspital Zürich, Dermatologische Klinik
City
Zürich
Country
Switzerland
Facility Name
Başkent University Faculty of Medicine
City
Ankara
Country
Turkey
Facility Name
Queen Mary University of London
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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