Clinical Trial: Safety and Efficacy of Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days in Subjects With Actinic Keratosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of Escalating Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days When Used on Full Face, Full Balding Scalp or Approximately 250 cm2
Brief Summary: To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel
Detailed Summary:
Sponsor: LEO Pharma
Current Primary Outcome:
- Part 1: Dose Limiting Toxicity based on LSRs up to and including Day 8 [ Time Frame: 8 days ]
- Part 2: Complete clearance of AKs [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Part 2: Reduction in AK count [ Time Frame: From baseline to Week 8 ]
- Part 2: Partial clearance of AKs [ Time Frame: Week 8 ]Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in the number of clinically visible AKs
Original Secondary Outcome: Same as current
Information By: LEO Pharma
Dates:
Date Received: March 25, 2013
Date Started: April 2013
Date Completion:
Last Updated: July 2, 2015
Last Verified: July 2015
