drugset / Trial / NCT03129321

Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis

NCT03129321

Phase 3 Completed 876 enrolled Mylan Inc. DPT Laboratories, Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1% to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis. To demonstrate the superiority of the Test and Reference (active) treatments over Placebo treatment in patients with tinea pedis. To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.

Timeline

Start
2016-03-15
Primary completion
2016-11-17
Completion
2016-11-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Econazole Unknown 1 % Topical

Indications