At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 203 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-Ib)
In Brief
A Phase 3 clinical trial evaluating PEP005 (ingenol mebutate) Gel and Vehicle gel for Actinic Keratoses. Completed, enrolled 203 participants across 17 sites.
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
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionOct 2009
TodayJul 2026
First PostedJul 21, 2009
Enrollment StartJul 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.9 years ago
Interventions
PEP005 (ingenol mebutate) Geldrug
two day treatment
Vehicle geldrug
two day treatment