CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 463 enrolled
Drug / intervention
Ingenol mebutate gel, 0.015% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01600014
NCT01600014Phase 3Completed

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

LEO Pharma·interventional·Posted May 16, 2012·Updated Mar 10, 2025

In Brief

A Phase 3 clinical trial evaluating Ingenol mebutate gel, 0.015% and Vehicle gel for Actinic Keratosis. Completed, enrolled 463 participants across 13 sites in 5 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2012
Enrollment StartMay 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago

Interventions

Ingenol mebutate gel, 0.015%drug

Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Vehicle geldrug

Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%