At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 367 enrolled
Drug / intervention
Vehicle +2 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 Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
In Brief
A Phase 3 clinical trial evaluating Cryotherapy, Vehicle, and 1 other intervention for Actinic Keratosis. Completed, enrolled 367 participants across 35 sites.
Detailed Summary
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartMar 2012
Primary CompletionJul 2013
TodayJul 2026
First PostedMar 1, 2012
Enrollment StartMar 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago
Interventions
Cryotherapyprocedure
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area
Vehicledrug
Field treatment with vehicle gel once daily for 3 consecutive days.
Ingenol metabutedrug
Field treatment with vehicle gel once daily for 3 consecutive days.