Clinical Trial: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

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

Official Title: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic

Brief Summary:

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Detailed Summary:
Sponsor: LEO Pharma

Current Primary Outcome:

• Part 1: Dose Limiting Toxicity up to and including Day 8 [ Time Frame: 8 days ]
• Part 2: Percent Reduction in AK Count [ Time Frame: 8 weeks ]
  Percent reduction in AK count from baseline to Week 8

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Part 2: Complete Clearance of AKs [ Time Frame: 8 Weeks ]
• Part 2: Partial Clearance of AKs [ Time Frame: 8 Weeks ]
  Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in AK count

Original Secondary Outcome: Same as current

Information By: LEO Pharma

Dates:
Date Received: April 18, 2014
Date Started: May 2014
Date Completion:
Last Updated: June 14, 2016
Last Verified: April 2016