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

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00735462
First received: August 14, 2008
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Genital Warts
Drug: 2.5% imiquimod cream
Drug: 3.75% imiquimod cream
Drug: Placebo cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 511
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
Drug: 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
Other Name: 2.5% imiquimod topical cream
Experimental: 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
Drug: 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
Other Name: 3.75% imiquimod topical cream
Placebo Comparator: Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks.
Drug: Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks
Other Name: Placebo topical cream

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735462

  Hide Study Locations
Locations
United States, Arkansas
NEA Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Northern Claifornia Research
Carmichael, California, United States, 95608
California State University - Chico
Chico, California, United States, 95929
Dermatology Research Associates
Los Angeles, California, United States, 90045
Conant Foundation
San Francisco, California, United States, 94114
United States, Colorado
Downtown Women's Healthcare
Denver, Colorado, United States, 80218
United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
United States, Georgia
PMI Health Research Group
Atlanta, Georgia, United States, 30312
Atlanta Women's Research Institute
Atlanta, Georgia, United States, 30342
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 61614
Howard Brown
Chicago, Illinois, United States, 60613
United States, Michigan
Valley Medical Center
Flint, Michigan, United States, 48507
Women's OB/GYN
Saginaw, Michigan, United States, 48604
United States, Missouri
Clayton Research Institute
St Louis, Missouri, United States, 63107
United States, New Jersey
Alliance Women's Research
Delran, New Jersey, United States, 08075
Women's Health Research Center
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Southwest Clinical Research
Albuquerque, New Mexico, United States, 87102
United States, New York
Boro Park ObGyn
New York, New York, United States, 10121
University Urology Associates
New York, New York, United States, 10016
United States, North Carolina
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
Complete Healthcare for Women
Columbus, Ohio, United States, 43213
Wright State University
Dayton, Ohio, United States, 45408
United States, Oklahoma
Heartland Health Institute
Tulsa, Oklahoma, United States, 74105
United States, Oregon
Clinical Trials of America
Eugene, Oregon, United States, 97401
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
The Clinical Trial Center
Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
Palmetto Clinical Research
Greer, South Carolina, United States, 29650
United States, Tennessee
Alpha Clinical Research
Clarksville, Tennessee, United States, 37043
Adams Patterson Gynecology and Obstetrics
Memphis, Tennessee, United States, 38102
Tennessee Women's Care
Nashville, Tennessee, United States, 37203
United States, Texas
DiscoveResearch
Bryan, Texas, United States, 77802
West Houston Clinical Research Services
Houston, Texas, United States, 77055
TMC Life Research
Houston, Texas, United States, 77054
Urology San Antonio Research
San Antonio, Texas, United States, 78229
The Center for Clinical Studies
Webster, Texas, United States, 77058
United States, Utah
Utah Clinical Trials
Salt Lake City, Utah, United States, 84107
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
CARE-ID
Annandale, Virginia, United States, 22003
Tidewater Clinical Reseach
Virginia Beach, Virginia, United States, 23456
Independence Family Medicine Clinical Research
Virginia Beach, Virginia, United States, 23513
United States, Washington
Women's Clinical Research Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
Study Director: Jason Wu, MD Graceway Pharmaceuticals
  More Information

No publications provided

Responsible Party: Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00735462     History of Changes
Other Study ID Numbers: GW01-0805
Study First Received: August 14, 2008
Results First Received: April 24, 2011
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
external genital warts
perianal warts
condylomata acuminata
human papilloma virus
HPV types 6 and 11

Additional relevant MeSH terms:
Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on August 26, 2014