Purpose

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.


Condition Intervention Phase
Genital Warts
 Drug: Imiquimod
 Phase IV

MedlinePlus related topics:   Genital Warts   Warts  

ChemIDplus related topics:   S 26308  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • Recurrence rate at 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

Estimated Enrollment:   120
Study Start Date:   June 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189293

Locations
Italy
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia     Recruiting
      MODENA, Italy, 41100
      Contact: Study Coordinator     39 059 4224377        
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia     Recruiting
      ASTI, Italy, 14100
      Contact: Study Coordinator     39 0141 489111        
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche     Recruiting
      ANCONA, Italy, 60123
      Contact: Study Coordinator     39 071 5962175        
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST     Recruiting
      GENOVA, Italy, 16132
      Contact: Study Coordinator     39 010 5600568        
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico     Recruiting
      BARI, Italy, 70100
      Contact: Study Coordinator     39 080 5555385        
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele     Recruiting
      CATANIA, Italy, 95124
      Contact: Study Coordinator     39 095 7435115        
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco     Recruiting
      Milano, Italy
      Contact: Study Coordinator     39 02 3904 2273        
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento     Recruiting
      MILANO, Italy, 20122
      Contact: Study Coordinator     39 0255031        
Clinica Ostetrica Ginecologica, Ospedale Careggi     Recruiting
      FIRENZE, Italy, 50134
      Contact: Study Coordinator     39 055 4277589        
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli     Recruiting
      PALERMO, Italy, 90127
      Contact: Study Coordinator     39 0916661111        
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore     Recruiting
      ROMA, Italy, 00168
      Contact: Study Coordinator     39 063 0154883        
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie     Recruiting
      Pozzuoli, Italy, 80078
      Contact: Study Coordinator     39 081 8552002        

Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG

Investigators
Principal Investigator:     Fausto Boselli, MD     Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia    
Italy
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia     Recruiting
      MODENA, Italy, 41100
      Contact: Study Coordinator     39 059 4224377        
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia     Recruiting
      ASTI, Italy, 14100
      Contact: Study Coordinator     39 0141 489111        
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche     Recruiting
      ANCONA, Italy, 60123
      Contact: Study Coordinator     39 071 5962175        
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST     Recruiting
      GENOVA, Italy, 16132
      Contact: Study Coordinator     39 010 5600568        
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico     Recruiting
      BARI, Italy, 70100
      Contact: Study Coordinator     39 080 5555385        
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele     Recruiting
      CATANIA, Italy, 95124
      Contact: Study Coordinator     39 095 7435115        
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco     Recruiting
      Milano, Italy
      Contact: Study Coordinator     39 02 3904 2273        
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento     Recruiting
      MILANO, Italy, 20122
      Contact: Study Coordinator     39 0255031        
Clinica Ostetrica Ginecologica, Ospedale Careggi     Recruiting
      FIRENZE, Italy, 50134
      Contact: Study Coordinator     39 055 4277589        
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli     Recruiting
      PALERMO, Italy, 90127
      Contact: Study Coordinator     39 0916661111        
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore     Recruiting
      ROMA, Italy, 00168
      Contact: Study Coordinator     39 063 0154883        
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie     Recruiting
      Pozzuoli, Italy, 80078
      Contact: Study Coordinator     39 081 8552002        
MEDA Pharma GmbH & Co. KG
Principal Investigator:     Fausto Boselli, MD     Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia    
  More Information

Study ID Numbers:   1526-IMIQ
First Received:   September 12, 2005
Last Updated:   May 16, 2007
ClinicalTrials.gov Identifier:   NCT00189293
Health Authority:   Italy: The Italian Medicines Agency

Keywords provided by MEDA Pharma GmbH & Co. KG:
External Ano-Genital Warts  
Ablative Therapy  
Aldara  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Interferons
Condyloma
Imiquimod
Recurrence
Skin Diseases, Infectious
Warts
Condylomata Acuminata
Condyloma acuminatum
Sexually Transmitted Diseases
Papillomavirus Infections
DNA Virus Infections
Interferon Alfa-2b

Additional relevant MeSH terms:
Warts
Interferon Inducers
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Tumor Virus Infections
Adjuvants, Immunologic
Pharmacologic Actions
Virus Diseases
Skin Diseases, Viral
Neoplasms
Therapeutic Uses

Source: National Library of Medicine (NLM) July 03, 2008

  


 
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