drugset / Trial / NCT02791308

Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

NCT02791308

Phase 3 Completed 587 enrolled Actavis Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Timeline

Start
2015-02
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pimecrolimus Small molecule 1 %

Indications