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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Genital Warts

Intervention / Treatment
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* Drug: Imiquimod
* Other: vehicle cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Imiquimod 5% cream | Drug: Imiquimod<br>* Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)<br>|
| Other: 2<br>vehicle cream | Other: vehicle cream<br>* vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recuurence rate 24 weeks after ablative therapy |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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External Ano-Genital Warts, Ablative Therapy, Aldara