clinical trial · NCT01926496
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
LEO Pharma·phase4·completed·n = 485
Actinic Keratosis (AK)Ingenol Mebutate Gel, 0.015%Imiquimod Cream, 5%
brief 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
started
Sep 11, 2013
primary completion
Jul 11, 2019
completion
Jul 11, 2019
last updated
Mar 7, 2025
official title
A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol