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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-12-31

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.

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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).

Conditions

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Genital Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Imiquimod 5% cream

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

Imiquimod 5% cream three times per week for 4 weeks (1 sachet)

1 or 2 sachet(s)

2

vehicle cream

Group Type OTHER

vehicle cream

Intervention Type OTHER

vehicle cream three times per week for 4 weeks (1 sachet)

1 or 2 sachet(s)

Interventions

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Imiquimod

Imiquimod 5% cream three times per week for 4 weeks (1 sachet)

1 or 2 sachet(s)

Intervention Type DRUG

vehicle cream

vehicle cream three times per week for 4 weeks (1 sachet)

1 or 2 sachet(s)

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No