At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 255 enrolled
Drug / intervention
PEP005 (ingenol mebutate) Gel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
In Brief
A Phase 3 clinical trial evaluating PEP005 (ingenol mebutate) Gel and Vehicle gel for Actinic Keratoses. Completed, enrolled 255 participants across 20 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratoses
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedAug 27, 2008
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.8 years ago
Interventions
PEP005 (ingenol mebutate) Geldrug
two day treatment
Vehicle geldrug
two day treatment