Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

Study Overview
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Brief Summary
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The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.

Official Title
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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts

Conditions
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Genital Warts

Intervention / Treatment
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* Drug: Imiquimod
* Drug: 3.75% imiquimod cream
* Drug: placebo cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts Negative pregnancy test (for women who are able to become pregnant) Exclusion Criteria: Women who are pregnant, lactating or planning to become pregnant during the study Evidence of clinically significant or unstable disease (such as stroke, heart attack) Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.

Ages Eligible for Study
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Minimum Age: 12 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: imiquimod cream<br>2.5% imiquimod cream applied daily to wart area for up to 8 weeks | Drug: Imiquimod<br>* daily topical application for up to 8 weeks<br>* Other names: imiquimod 2.5% topical creram;|
| Experimental: 3.75% imiquimod cream<br>3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. | Drug: 3.75% imiquimod cream<br>* 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.<br>* Other names: 3.75% imiquimod topical cream;|
| Placebo Comparator: placebo cream<br>placebo cream applied daily to wart areas for up to 8 weeks | Drug: placebo cream<br>* placebo cream applied daily to wart areas for up to 8 weeks<br>* Other names: placebo matching cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study | Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points. | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. | Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit. Rest period was a temporary interruption of dosing dur to intolerable LSRs. | Up to 16 weeks | 
| Treatment Related Adverse Events | Numbers of subjects in each treatment group reporting one or more adverse events | Up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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external genital warts, perianal warts, condylomata acuminata, venereal warts, HPV types 6 and 11