drugset / Trial / NCT03200912

An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis

NCT03200912

Phase 3 Completed 507 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, 0.015% 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.

Timeline

Start
2016-08-19
Primary completion
2017-03-07
Completion
2017-03-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator ingenol mebutate Small molecule 0.015 % Topical

Indications