Clinical Trial: Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Tota
Brief Summary: Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
Detailed Summary:
Sponsor: Peplin
Current Primary Outcome: Safety and tolerability (incidence of AEs, SAEs and skin responses) [ Time Frame: Screening to End of Study (Day 57) ]
Original Primary Outcome: Safety and tolerability (incidence of AEs, SAEs and skin responses) [ Time Frame: Screening to End of Study ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Peplin
Dates:
Date Received: April 15, 2008
Date Started: April 2008
Date Completion:
Last Updated: September 11, 2015
Last Verified: November 2008