Clinical Trial: A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

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

Official Title: Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Che

Brief Summary:

Part 1:

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

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Detailed Summary:
Sponsor: LEO Pharma

Current Primary Outcome:

• Part 1: Dose Limiting Toxicity based on Local Skin Responses (LSRs) up to and including Day 8 [ Time Frame: 8 days ]
• Part 2: Percent reduction in actinic keratosis (AK) counts from baseline to Week 8 [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Part 2: Complete clearance of AKs at week 8 [ 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 AK count

Original Secondary Outcome: Same as current

Information By: LEO Pharma

Dates:
Date Received: August 12, 2013
Date Started: October 2013
Date Completion:
Last Updated: October 20, 2015
Last Verified: October 2015