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

May 19, 2011 updated by: Graceway Pharmaceuticals, LLC

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety 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)

470

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
    • Alabama
      • Mobile, Alabama, United States, 36608
        • WILMAX Clinical Research
      • Montgomery, Alabama, United States, 36116
        • Montgomery Women's Health Associates
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
      • Tempe, Arizona, United States, 85282
        • Premier Pharmaceutical Research
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research
    • California
      • Fountain Valley, California, United States, 92708
        • Edinger Medical Group Clinical Research Center
      • Fremont, California, United States, 94538
        • East Bay Dermatology Medical Group
      • San Luis Obispo, California, United States, 93405
        • Coastal Medical Research Group
      • Torrance, California, United States, 90505
        • Torrance Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Clinicos, LLC
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Visions Clinical Research
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • Sunrise, Florida, United States, 33316
        • Discovery Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Perimeter Institute For Clinical Research
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
      • Roswell, Georgia, United States, 30075
        • Atlanta North Gynecology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Infectious Disease Research Group
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Dermatology Practice
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Clinic
    • New York
      • Great Neck, New York, United States, 11021
        • Private Practice
      • Purchase, New York, United States, 10577
        • Private Practice
      • Stony Brook, New York, United States, 11794
        • State University of NY Stony Brook
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
        • Philadelphia Institute of Dermatology
    • Texas
      • Austin, Texas, United States, 78705
        • Professional Quality Research, Women Partners in Health
      • Austin, Texas, United States, 78759
        • Professional Quality Research, The Urology Team
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center Dermatology Dept
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research

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

12 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 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: imiquimod cream
2.5% imiquimod cream applied daily to wart area for up to 8 weeks
Drug: Imiquimod
daily topical application for up to 8 weeks
Other Names:
  • imiquimod 2.5% topical creram
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
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 matching cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
Time Frame: Up to 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Time Frame: Up to 16 weeks

Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.

Rest period was a temporary interruption of dosing dur to intolerable LSRs.
Up to 16 weeks
Treatment Related Adverse Events
Time Frame: Up to 16 weeks
Numbers of subjects in each treatment group reporting one or more adverse events
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

May 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW01-0801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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