NCT01532453

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Spirig Pharma Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratoses
• Squamous Cell Carcinomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-02-14
• Last updated: 2016-01-08
• Results posted: 2016-01-08

Locations

10 sites across 9 countries: Austria, Czechia, France, Germany, Ireland, Netherlands, Switzerland, Turkey (Türkiye), United Kingdom