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

NCT ID: NCT00674739

Last Updated: 2011-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-07-31

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.

Conditions

Genital Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

imiquimod cream

2.5% imiquimod cream applied daily to wart area for up to 8 weeks

Group Type: EXPERIMENTAL

Imiquimod

Intervention Type: DRUG

daily topical application for up to 8 weeks

3.75% imiquimod cream

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.

Group Type: EXPERIMENTAL

3.75% imiquimod cream

Intervention Type: DRUG

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.

placebo cream

placebo cream applied daily to wart areas for up to 8 weeks

Group Type: PLACEBO_COMPARATOR

placebo cream

Intervention Type: DRUG

placebo cream applied daily to wart areas for up to 8 weeks

Interventions

Imiquimod

daily topical application for up to 8 weeks

Intervention Type: DRUG

3.75% imiquimod cream

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.

Intervention Type: DRUG

placebo cream

placebo cream applied daily to wart areas for up to 8 weeks

Intervention Type: DRUG

Other Intervention Names

imiquimod 2.5% topical creram; 3.75% imiquimod topical cream; placebo matching cream

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Graceway Pharmaceuticals, LLC

Principal Investigators

Jason Wu, MD

Role: STUDY_DIRECTOR

Graceway Pharmaceuticals

Locations

WILMAX Clinical Research

Mobile, Alabama, United States

Montgomery Women's Health Associates

Montgomery, Alabama, United States

Women's Health Research

Phoenix, Arizona, United States

Precision Trials

Phoenix, Arizona, United States

Premier Pharmaceutical Research

Tempe, Arizona, United States

Visions Clinical Research

Tucson, Arizona, United States

Edinger Medical Group Clinical Research Center

Fountain Valley, California, United States

East Bay Dermatology Medical Group

Fremont, California, United States

Coastal Medical Research Group

San Luis Obispo, California, United States

Torrance Clinical Research

Torrance, California, United States

Clinicos, LLC

Colorado Springs, Colorado, United States

Colorado Medical Research Center

Denver, Colorado, United States

Visions Clinical Research

Boynton Beach, Florida, United States

Segal Institute for Clinical Research

North Miami, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Discovery Clinical Research

Sunrise, Florida, United States

Perimeter Institute for Clinical Research

Atlanta, Georgia, United States

Medical College of Georgia

Augusta, Georgia, United States

Atlanta North Gynecology

Roswell, Georgia, United States

Indiana University Infectious Disease Research Group

Indianapolis, Indiana, United States

Dermatology Practice

Ann Arbor, Michigan, United States

Alegent Health Clinic

Omaha, Nebraska, United States

Private Practice

Great Neck, New York, United States

Private Practice

Purchase, New York, United States

State University of NY Stony Brook

Stony Brook, New York, United States

Philadelphia Institute of Dermatology

Philadelphia, Pennsylvania, United States

Professional Quality Research, Women Partners in Health

Austin, Texas, United States

Professional Quality Research, The Urology Team

Austin, Texas, United States

University of Texas Southwestern Medical Center Dermatology Dept

Dallas, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GW01-0801

Identifier Type: -

Identifier Source: org_study_id