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

Sponsor

MEDA Pharma GmbH & Co. KG (Industry)

Overall Status

Completed

CT.gov ID

NCT00189293

Collaborator

(none)

128

Enrollment

Locations

Arms

Duration (Months)

10.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Jun 1, 2005

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

recuurence rate 24 weeks after ablative therapy [24 weeks]

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

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