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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189293
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 6, 2011
Information provided by:
MEDA Pharma GmbH & Co. KG

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.

Condition or disease Intervention/treatment Phase
Genital Warts Drug: Imiquimod Other: vehicle cream Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: 1
Imiquimod 5% cream
Drug: Imiquimod

Imiquimod 5% cream three times per week for 4 weeks (1 sachet)

1 or 2 sachet(s)

vehicle cream
Other: vehicle cream

vehicle cream three times per week for 4 weeks (1 sachet)

1 or 2 sachet(s)

Primary Outcome Measures :
  1. recuurence rate 24 weeks after ablative therapy [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: n.a. ]
  2. Recurrence rate at 4 and 12 weeks post ablation [ Time Frame: 4 and 12 weeks ]
  3. Reduction of EGW area [ Time Frame: 4 and 12 weeks ]
  4. Healing and cosmetic outcome [ Time Frame: 4, 12 and 24 weeks ]
  5. Local and general tolerability [ Time Frame: n.a. ]
  6. Percent of complete clearance after initial topical treatment [ Time Frame: up to 6 weeks after initial topical treatment ]
  7. Occurrence of new lesions [ Time Frame: n.a. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189293

Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
Ancona, Italy, 60123
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
Asti, Italy, 14100
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico
Bari, Italy, 70100
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele
Catania, Italy, 95124
Clinica Ostetrica Ginecologica, Ospedale Careggi
Firenze, Italy, 50134
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST
Genova, Italy, 16132
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
Milano, Italy, 20122
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
Milano, Italy
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
Modena, Italy, 41100
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli
Palermo, Italy, 90127
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie
Pozzuoli, Italy, 80078
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Principal Investigator: Fausto Boselli, MD Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia

Responsible Party: Joachim Maus, MD, Director Clinical Development, Meda Pharma GmbH & Co. KG Identifier: NCT00189293     History of Changes
Other Study ID Numbers: 1526-IMIQ
2004-004654-19 ( EudraCT Number )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: September 2008

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

Additional relevant MeSH terms:
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers