drugset / Trial / NCT01820260

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

NCT01820260

Phase 1/2 Completed 395 enrolled LEO Pharma
RandomizedSequentialQuadruple-blindTreatment

Summary

To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Timeline

Start
2013-04
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ingenol mebutate Small molecule 0.005 %
Subject ingenol mebutate Small molecule 0.008 %
Subject ingenol mebutate Small molecule 0.012 %
Subject ingenol mebutate Small molecule 0.018 %
Subject ingenol mebutate Small molecule 0.027 %
Subject ingenol mebutate Small molecule 0.04 %
Subject ingenol mebutate Small molecule 0.06 %

Indications