Clinical trial NCT00735462: Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Official title: A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genital Warts
Keywords: external genital warts
perianal warts
condylomata acuminata
human papilloma virus
HPV types 6 and 11
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 511
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Carmichael
country: United States
facility: Northern Claifornia Research
state: California
city: Chico
country: United States
facility: California State University - Chico
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Francisco
country: United States
facility: Conant Foundation
state: California
city: Denver
country: United States
facility: Downtown Women's Healthcare
state: Colorado
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Atlanta
country: United States
facility: PMI Health Research Group
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Chicago
country: United States
facility: Howard Brown
state: Illinois
city: Flint
country: United States
facility: Valley Medical Center
state: Michigan
city: Saginaw
country: United States
facility: Women's OB/GYN
state: Michigan
city: St Louis
country: United States
facility: Clayton Research Institute
state: Missouri
city: Delran
country: United States
facility: Alliance Women's Research
state: New Jersey
city: Lawrenceville
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest Clinical Research
state: New Mexico
city: New York
country: United States
facility: University Urology Associates
state: New York
city: New York
country: United States
facility: Boro Park ObGyn
state: New York
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Dayton
country: United States
facility: Wright State University
state: Ohio
city: Tulsa
country: United States
facility: Heartland Health Institute
state: Oklahoma
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Greer
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: Adams Patterson Gynecology and Obstetrics
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Women's Care
state: Tennessee
city: Bryan
country: United States
facility: DiscoveResearch
state: Texas
city: Houston
country: United States
facility: TMC Life Research
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Webster
country: United States
facility: The Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Utah Clinical Trials
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Annandale
country: United States
facility: CARE-ID
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Reseach
state: Virginia
city: Virginia Beach
country: United States
facility: Independence Family Medicine Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
Study officials:
affiliation: Graceway Pharmaceuticals
name: Jason Wu, MD
role: STUDY_DIRECTOR
References: