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

NCT01532453 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2016-01-08

Study results available
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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.

Conditions

  • Actinic Keratoses
  • Squamous Cell Carcinomas

Interventions

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.

Sponsors & Collaborators

  • Spirig Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Claas Ulrich, MD · Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Ireland
  • Netherlands
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532453 on ClinicalTrials.gov