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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01532453
• Other study ID #: SP 488/2009
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2012
• Last updated: December 3, 2015
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: Spirig Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: SwissmedicGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesFrance: Institutional Ethical CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Czech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlIreland: Irish Medicines BoardIreland: Medical Ethics Research CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Institute for Health ResearchTurkey: Ethics CommitteeTurkey: Ministry of HealthAustria: EthikkommissionAustria: Federal Office for Safety in Health CareNetherlands: Dutch Health Care InspectorateNetherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Actinic Keratoses
• Carcinoma, Squamous Cell
• Keratosis
• Keratosis, Actinic
• Squamous Cell Carcinomas

Intervention

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

Other:
• Standard Sun Protection Measures
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Spirig Pharma Ltd.

Countries where clinical trial is conducted

Austria,  Czech Republic,  France,  Germany,  Ireland,  Netherlands,  Switzerland,  Turkey,  United Kingdom, 

Outcome

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