drugset / Trial / NCT02654769

A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis

NCT02654769

Phase 3 Completed 441 enrolled Actavis Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-02
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator ingenol mebutate Small molecule 0.05 % Topical

Indications