At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Study of Hyloris Developments' Podofilox Topical Gel 0.5% Compared to Allergan's Condylox® Gel 0.5% in Male and Female Patients With External Anogenital Warts.
In Brief
A Phase 3 clinical trial evaluating Podofilox Gel 0.5%, Condylox Topical Gel 0.5%, and 1 other intervention for External Anogenital Warts. Completed, enrolled 466 participants across 17 sites in 3 countries.
Detailed 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study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
Study Details
Timeline
Interventions
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles