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

Meda Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Genital Warts

Treatments

Drug: Imiquimod

Other: vehicle cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT00189293

2004-004654-19 (EudraCT Number)

1526-IMIQ

Details and patient eligibility

About

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.

Full 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).

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.