Clinical Trial: Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

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

Official Title: A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head L

Brief Summary: This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

Detailed Summary:
Sponsor: Peplin

Current Primary Outcome: To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. [ Time Frame: Day 43 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations. [ Time Frame: Day 43 ]

Original Secondary Outcome: Same as current

Information By: Peplin

Dates:
Date Received: October 3, 2010
Date Started: October 2010
Date Completion:
Last Updated: January 23, 2011
Last Verified: January 2011