Who is sponsoring NCT01600014?

NCT01600014 is sponsored by LEO Pharma.

What condition does NCT01600014 study?

NCT01600014 studies Actinic Keratosis.

What drugs are being tested in NCT01600014?

Interventions: Ingenol mebutate gel, 0.015%, Vehicle gel.

What is the status of NCT01600014?

NCT01600014 is currently COMPLETED.

Last reviewed 2025-02-21 · How we verify

Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

NCT01600014 Phase 3 COMPLETED Results posted

The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

Details

Lead sponsor	LEO Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	463
Start date	2012-05
Completion	2014-02

Conditions

Actinic Keratosis

Interventions

Ingenol mebutate gel, 0.015%
Vehicle gel

Primary outcomes

Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation — 8 weeks after randomisation
The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)

Countries

Australia, Canada, France, Germany, United Kingdom