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

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 Other: vehicle cream	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Genital Warts Warts

Drug Information available for: Imiquimod

U.S. FDA Resources

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

Primary Outcome Measures:

recuurence rate 24 weeks after ablative therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to recurrence [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]
Recurrence rate at 4 and 12 weeks post ablation [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: Yes ]
Reduction of EGW area [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: Yes ]
Healing and cosmetic outcome [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
Local and general tolerability [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]
Percent of complete clearance after initial topical treatment [ Time Frame: up to 6 weeks after initial topical treatment ] [ Designated as safety issue: Yes ]
Occurrence of new lesions [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]

Enrollment:	128
Study Start Date:	June 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Imiquimod 5% cream	Drug: Imiquimod Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)
2 vehicle cream	Other: vehicle cream vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)

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).

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
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
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
Milano, Italy
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
Milano, Italy, 20122
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

Investigators

Principal Investigator:

Fausto Boselli, MD

Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia

More Information

No publications provided

Responsible Party:	Joachim Maus, MD, Director Clinical Development, Meda Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00189293 History of Changes
Other Study ID Numbers:	1526-IMIQ, 2004-004654-19
Study First Received:	September 12, 2005
Last Updated:	January 5, 2011
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by MEDA Pharma GmbH & Co. KG:

External Ano-Genital Warts
Ablative Therapy
Aldara

Additional relevant MeSH terms:

Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious

Skin Diseases
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 23, 2013