NCT01926496

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Actinic Keratosis (AK)

Interventions

Type	Name	Description
DRUG	Ingenol Mebutate Gel, 0.015%	Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
DRUG	Imiquimod Cream, 5%	Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs

Timeline

• Start date: 2013-09-11
• Primary completion: 2019-07-11
• Completion: 2019-07-11
• First posted: 2013-08-21
• Last updated: 2025-03-07
• Results posted: 2020-07-29

Locations

46 sites across 3 countries: France, Germany, United Kingdom