Clinical Trial: Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremit

Brief Summary: This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Detailed Summary:
Sponsor: LEO Pharma

Current Primary Outcome: Complete clearance of AKs [ Time Frame: Week 8 ]

To evaluate efficacy of ingenol mebutate gel after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in AK count [ Time Frame: From baseline to week 8 ]
  • Partial clearance of AKs [ Time Frame: From baseline to week 8 ]


Original Secondary Outcome: Same as current

Information By: LEO Pharma

Dates:
Date Received: November 21, 2013
Date Started: January 2014
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016