CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 507 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/NCT03200912
NCT03200912Phase 3Completed
CompareCT.gov

A Multicenter Randomized Doubleblind Vehicle-controlled Parallel Comparison Study to Determine Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.015% and Picato® Gel 0.015% in Subjects With Actinic Keratosis on the Face or Scalp

Actavis Inc.·interventional·Posted Jun 27, 2017·Updated Jan 14, 2020

In Brief

A Phase 3 clinical trial evaluating Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, and 1 other intervention for ACTINIC KERATOSIS. Completed, enrolled 507 participants across 23 sites.

Detailed Summary

The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsACTINIC KERATOSIS
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 27, 2017
Enrollment StartAug 19, 2016
Primary CompletionMar 7, 2017
Study CompletionMar 22, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.0 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.