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

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

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.

Study Overview

• Status: Completed
• Conditions: Genital Warts
• Intervention / Treatment: Drug: Imiquimod; Other: vehicle cream

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
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)
Other: 2; vehicle cream	Other: vehicle cream; vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recuurence rate 24 weeks after ablative therapy	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to recurrence
Recurrence rate at 4 and 12 weeks post ablation	4 and 12 weeks
Reduction of EGW area	4 and 12 weeks
Healing and cosmetic outcome	4, 12 and 24 weeks
Local and general tolerability
Percent of complete clearance after initial topical treatment	up to 6 weeks after initial topical treatment
Occurrence of new lesions

Collaborators and Investigators

• Sponsor: MEDA Pharma GmbH & Co. KG
• Investigators: Principal Investigator: Fausto Boselli, MD, Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Aldara; External Ano-Genital Warts; Ablative Therapy
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Condylomata Acuminata; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: 1526-IMIQ; 2004-004654-19 (EudraCT Number)