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

NCT03532776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2021-07-27

Study results available
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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study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations

Conditions

  • External Anogenital Warts

Interventions

DRUG

Podofilox Gel 0.5%

Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

DRUG

Condylox Topical Gel 0.5%

Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

DRUG

Placebo Gel

Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • Dermax SA

    lead INDUSTRY

Principal Investigators

  • Evgeniy Cherepanov, MD · bioRASI, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2018-12-02
Completion
2020-01-31
FDA Drug
Yes

Countries

  • United States
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532776 on ClinicalTrials.gov