At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Ingenol mebutate gel 0.05 % +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 Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities
In Brief
A Phase 3 clinical trial evaluating Ingenol mebutate gel 0.05 % and Ingenol mebutate gel 0.015 % for Actinic Keratosis. Completed, enrolled 200 participants across 1 site.
Detailed Summary
The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedFeb 2013
Primary CompletionJan 2014
TodayJul 2026
First PostedFeb 8, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.4 years ago
Interventions
Ingenol mebutate gel 0.05 %drug
Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially
Ingenol mebutate gel 0.015 %drug
Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially