drugset / Trial / NCT03532776

Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts

NCT03532776 ↗

Phase 3 Completed 466 enrolled Dermax SA bioRASI, LLC · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations

Timeline

Start
2018-04-20
Primary completion
2018-12-02
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Podofilox Small molecule 0.5 % Topical