Status:

COMPLETED

Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts

Lead Sponsor:

MEDA Pharma GmbH & Co. KG

Conditions:

Genital Warts

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 week...

Detailed Description

To compare the recurrence rate 24 weeks after ablative therapy in subjects with external genital warts trated with imiquimod, 3 applications per week for 4 weeks followed by ablative therapy versus ve...

Eligibility Criteria

Inclusion

  • Subjects with at least 1 visible genital or perianal wart
  • Total wart area 1 to 40 square centimeters.

Exclusion

  • Pregnant or lactating women
  • Known other sexually transmitted disease
  • Evidence of a clinically significant immunodeficiency
  • Evidence of unstable cardiovascular, pulmonary, hematological, hepatic, renal, endocrine, collagen vascular, neurological or gastrointestinal abnormality or disease.
  • Treatment within the 4 weeks prior to the Randomization Visit with any of the following systemic or topical treatments: interferons, interferon inducers, immunomodulators, immunosuppressive drugs, antiviral drugs (except for systemic acyclovir, valacyclovir and famciclovir), cytotoxic drugs, investigational drugs, or any drugs known to have major organ toxicity.

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

128 Patients enrolled

Trial Details

Trial ID

NCT00189293

Start Date

June 1 2005

End Date

December 1 2007

Last Update

February 7 2022

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Clinica Ostetrica e Ginecologica Università Politecnica delle Marche

Ancona, Italy, 60123

2

Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia

Asti, Italy, 14100

3

Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico

Bari, Italy, 70100

4

Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele

Catania, Italy, 95124