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

June 21, 2011 updated by: Graceway Pharmaceuticals, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 3.75% imiquimod topical cream
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 Names:
  • 2.5% 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 Names:
  • Placebo topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
Time Frame: Up to 16 weeks
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Graceway Pharmaceuticals, LLC

Investigators

  • Study Director: Jason Wu, MD, Graceway Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW01-0805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Genital Warts

Clinical Trials on 2.5% imiquimod cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe