drugset / Trial / NCT01926496

Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

NCT01926496

Phase 4 Completed 485 enrolled LEO Pharma
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment

Timeline

Start
2013-09-11
Primary completion
2019-07-11
Completion
2019-07-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imiquimod Other / unclassified 5 % Topical
Subject ingenol mebutate Small molecule 0.015 % Topical

Indications