At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 269 enrolled
Drug / intervention
PEP005 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
In Brief
A Phase 3 clinical trial evaluating PEP005 Gel and Vehicle gel for Actinic Keratosis. Completed, enrolled 269 participants across 21 sites in 2 countries.
Detailed Summary
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionSep 2009
TodayJul 2026
First PostedJun 8, 2009
Enrollment StartJun 1, 2009
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.1 years ago
Interventions
PEP005 Geldrug
0.015%, three day treatment
Vehicle geldrug
Vehicle gel, three day treatment