CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 441 enrolled
Drug / intervention
Ingenol Mebutate (Picato®) +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.

Search/NCT02654769
NCT02654769Phase 3Completed
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Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities

Actavis Inc.·interventional·Posted Jan 13, 2016·Updated May 12, 2020

In Brief

A Phase 3 clinical trial evaluating Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, and 1 other intervention for Actinic Keratosis. Completed, enrolled 441 participants across 22 sites.

Detailed Summary

The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 13, 2016
Enrollment StartFeb 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.5 years ago

Interventions

Ingenol Mebutate (Picato®)drug

Brand product

Generic Ingenol Mebutatedrug

Generic formulated to have the same therapeutic effect of the brand

Vehicle Foamdrug

It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.