Clinical trial NCT00674739: Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety 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
venereal warts
HPV types 6 and 11
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 470
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 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 With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
timeFrame: Up to 16 weeks
measure: Treatment Related Adverse Events
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: WILMAX Clinical Research
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Women's Health Associates
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Tempe
country: United States
facility: Premier Pharmaceutical Research
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Fountain Valley
country: United States
facility: Edinger Medical Group Clinical Research Center
state: California
city: Fremont
country: United States
facility: East Bay Dermatology Medical Group
state: California
city: San Luis Obispo
country: United States
facility: Coastal Medical Research Group
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Sunrise
country: United States
facility: Discovery Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Roswell
country: United States
facility: Atlanta North Gynecology
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Infectious Disease Research Group
state: Indiana
city: Ann Arbor
country: United States
facility: Dermatology Practice
state: Michigan
city: Omaha
country: United States
facility: Alegent Health Clinic
state: Nebraska
city: Great Neck
country: United States
facility: Private Practice
state: New York
city: Purchase
country: United States
facility: Private Practice
state: New York
city: Stony Brook
country: United States
facility: State University of NY Stony Brook
state: New York
city: Philadelphia
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Austin
country: United States
facility: Professional Quality Research, Women Partners in Health
state: Texas
city: Austin
country: United States
facility: Professional Quality Research, The Urology Team
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Dermatology Dept
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
Study officials:
affiliation: Graceway Pharmaceuticals
name: Jason Wu, MD
role: STUDY_DIRECTOR
References: