Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
1 other identifier
interventional
470
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2008
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 18, 2011
CompletedMay 24, 2011
May 1, 2011
1.2 years
May 7, 2008
April 24, 2011
May 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Up to 16 weeks
Treatment Related Adverse Events
Up to 16 weeks
Study Arms (3)
imiquimod cream
EXPERIMENTAL2.5% imiquimod cream applied daily to wart area for up to 8 weeks
3.75% imiquimod cream
EXPERIMENTAL3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
placebo cream
PLACEBO COMPARATORplacebo cream applied daily to wart areas for up to 8 weeks
Interventions
daily topical application for up to 8 weeks
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
placebo cream applied daily to wart areas for up to 8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
WILMAX Clinical Research
Mobile, Alabama, 36608, United States
Montgomery Women's Health Associates
Montgomery, Alabama, 36116, United States
Women's Health Research
Phoenix, Arizona, 85015, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Premier Pharmaceutical Research
Tempe, Arizona, 85282, United States
Visions Clinical Research
Tucson, Arizona, 85712, United States
Edinger Medical Group Clinical Research Center
Fountain Valley, California, 92708, United States
East Bay Dermatology Medical Group
Fremont, California, 94538, United States
Coastal Medical Research Group
San Luis Obispo, California, 93405, United States
Torrance Clinical Research
Torrance, California, 90505, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Discovery Clinical Research
Sunrise, Florida, 33316, United States
Perimeter Institute for Clinical Research
Atlanta, Georgia, 30338, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Atlanta North Gynecology
Roswell, Georgia, 30075, United States
Indiana University Infectious Disease Research Group
Indianapolis, Indiana, 46202, United States
Dermatology Practice
Ann Arbor, Michigan, 48103, United States
Alegent Health Clinic
Omaha, Nebraska, 68124, United States
Private Practice
Great Neck, New York, 11021, United States
Private Practice
Purchase, New York, 10577, United States
State University of NY Stony Brook
Stony Brook, New York, 11794, United States
Philadelphia Institute of Dermatology
Philadelphia, Pennsylvania, 19144, United States
Professional Quality Research, Women Partners in Health
Austin, Texas, 78705, United States
Professional Quality Research, The Urology Team
Austin, Texas, 78759, United States
University of Texas Southwestern Medical Center Dermatology Dept
Dallas, Texas, 75390, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Babilon, Vice President, Product Development
- Organization
- Graceway Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Jason Wu, MD
Graceway Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 8, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 24, 2011
Results First Posted
May 18, 2011
Record last verified: 2011-05