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

Primary Purpose

Genital Warts

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Imiquimod
vehicle cream
Sponsored by
MEDA Pharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Warts focused on measuring External Ano-Genital Warts, Ablative Therapy, Aldara

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with at least 1 visible genital or perianal wart Total wart area 1 to 40 square centimeters. Exclusion Criteria: 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.

Sites / Locations

  • Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
  • Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
  • Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico
  • Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele
  • Clinica Ostetrica Ginecologica, Ospedale Careggi
  • Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST
  • Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
  • Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
  • Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
  • Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli
  • Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie
  • Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Imiquimod 5% cream

vehicle cream

Outcomes

Primary Outcome Measures

recuurence rate 24 weeks after ablative therapy

Secondary Outcome Measures

Time to recurrence
Recurrence rate at 4 and 12 weeks post ablation
Reduction of EGW area
Healing and cosmetic outcome
Local and general tolerability
Percent of complete clearance after initial topical treatment
Occurrence of new lesions

Full Information

First Posted
September 12, 2005
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00189293
Brief Title
Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
Official Title
Multicenter, Randomised, Double-blind, Vehicle-controlled Study Comparing Recurrence Rate Following Imiquimod 5% Cream or Vehicle 3 Times Per Week for 4 Weeks Prior to Ablative Therapy in Subjects Suffering From External Ano-Genital Warts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MEDA Pharma GmbH & Co. KG

4. Oversight

5. Study Description

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 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone.
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 vehicle, 3 applications per week for 4 weeks followed by ablative therapy. A recurrence is defined as the investoigator-assessed occurrence of lesion(s) within the baseline area cleared by the treatment: imiquimod/vehicle then ablative therapy (either the initial ablative therápy session (A0), or if required for complete clearance of baseline lesions, a second ablative therapy session (A2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts
Keywords
External Ano-Genital Warts, Ablative Therapy, Aldara

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Imiquimod 5% cream
Arm Title
2
Arm Type
Other
Arm Description
vehicle cream
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)
Intervention Type
Other
Intervention Name(s)
vehicle cream
Intervention Description
vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)
Primary Outcome Measure Information:
Title
recuurence rate 24 weeks after ablative therapy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Time to recurrence
Title
Recurrence rate at 4 and 12 weeks post ablation
Time Frame
4 and 12 weeks
Title
Reduction of EGW area
Time Frame
4 and 12 weeks
Title
Healing and cosmetic outcome
Time Frame
4, 12 and 24 weeks
Title
Local and general tolerability
Title
Percent of complete clearance after initial topical treatment
Time Frame
up to 6 weeks after initial topical treatment
Title
Occurrence of new lesions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with at least 1 visible genital or perianal wart Total wart area 1 to 40 square centimeters. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fausto Boselli, MD
Organizational Affiliation
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico
City
Bari
ZIP/Postal Code
70100
Country
Italy
Facility Name
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Clinica Ostetrica Ginecologica, Ospedale Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
City
Milano
Country
Italy
Facility Name
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie
City
Pozzuoli
ZIP/Postal Code
80078
Country
Italy
Facility Name
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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