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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01532453
Other study ID # SP 488/2009
Secondary ID
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


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
See also
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Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
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