Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts

Phase 3

Completed

Interventions: Drug: 3.75% imiquimod cream
Drug: 2.5% imiquimod cream
Drug: Placebo cream

Brief Summary: 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.

Recruitment & Eligibility

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 types 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

Arm && Interventions

Group	Intervention	Description
3.75% imiquimod cream	3.75% imiquimod cream	3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
2.5% imiquimod cream	2.5% imiquimod cream	2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
Placebo cream	Placebo cream	Placebo cream applied daily to wart areas for up to 8 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.	Up to 16 weeks	The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period	Up to 16 weeks	Treatment related defined as "probably related" or "related" by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators. Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction.

Locations (43): NEA Clinic
🇺🇸
Jonesboro, Arkansas, United States
Northern Claifornia Research
🇺🇸
Carmichael, California, United States
California State University - Chico
🇺🇸
Chico, California, United States
Dermatology Research Associates
🇺🇸
Los Angeles, California, United States
Conant Foundation
🇺🇸
San Francisco, California, United States
Downtown Women's Healthcare
🇺🇸
Denver, Colorado, United States
Altus Research
🇺🇸
Lake Worth, Florida, United States
PMI Health Research Group
🇺🇸
Atlanta, Georgia, United States
Atlanta Women's Research Institute
🇺🇸
Atlanta, Georgia, United States
Altman Dermatology Associates
🇺🇸
Arlington Heights, Illinois, United States
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NEA Clinic
🇺🇸Jonesboro, Arkansas, United States