NCT01600014

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Ingenol mebutate gel, 0.015%	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%
DRUG	Vehicle gel	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%

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-05-16
• Last updated: 2025-03-10
• Results posted: 2016-05-09

Locations

13 sites across 5 countries: Australia, Canada, France, Germany, United Kingdom