Overview

This trial is active, not recruiting.

Conditions actinic keratoses, squamous cell carcinomas
Treatments md-3511356, standard sun protection measures
Phase phase 3
Sponsor Spirig Pharma Ltd.
Start date November 2010
End date March 2015
Trial size 300 participants
Trial identifier NCT01532453, SP 488/2009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
standard sun protection measures
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
(Experimental)
md-3511356
Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

Primary Outcomes

Measure
Number of new clinically diagnosed actinic keratoses or squamous cell carcinomas
time frame: 2 Years

Secondary Outcomes

Measure
Number of patients with new actinic keratoses, squamous cell carcinomas or basal cell carcinomas
time frame: 2 Years

Eligibility Criteria

Male or female participants at least 40 years old.

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 kryotherapy 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

Additional Information

Official title An Open, Multicentre, Randomised, Inter-individual Comparative, Prospective Clinical Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Outpatients After Solid Organ Transplantations for the Prevention of UV-induced Infections and Carcinogenic Skin Alterations.
Principal investigator Claas Ulrich, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Spirig Pharma Ltd..