drugset / Trial / NCT02866695

Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients

NCT02866695

Phase 4 Completed 20 enrolled University of California, San Francisco
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney transplant recipients and 10 lung transplant recipients. The investigators have selected these two populations as the represent the spectrum of solid organ transplantation: kidney transplant recipients are the largest transplant population, but have lower levels of immunosuppression and skin cancer risk. Lung transplant recipients have the highest burden of skin cancer and actinic keratoses.

Timeline

Start
2016-10-06
Primary completion
2018-07-02
Completion
2018-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ingenol mebutate Small molecule 0.015 % Topical

Indications