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

Primary Purpose

Genital Warts

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
2.5% imiquimod cream
3.75% imiquimod cream
Placebo cream
Sponsored by
Graceway Pharmaceuticals, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Warts focused on measuring external genital warts, perianal warts, condylomata acuminata, human papilloma virus, HPV types 6 and 11

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NEA Clinic
  • Northern Claifornia Research
  • California State University - Chico
  • Dermatology Research Associates
  • Conant Foundation
  • Downtown Women's Healthcare
  • Altus Research
  • PMI Health Research Group
  • Atlanta Women's Research Institute
  • Altman Dermatology Associates
  • Howard Brown
  • Valley Medical Center
  • Women's OB/GYN
  • Clayton Research Institute
  • Alliance Women's Research
  • Women's Health Research Center
  • Southwest Clinical Research
  • University Urology Associates
  • Boro Park ObGyn
  • Crescent Medical Research
  • Piedmont Medical Research
  • Rapid Medical Research
  • Complete Healthcare for Women
  • Wright State University
  • Heartland Health Institute
  • Clinical Trials of America
  • Westover Heights Clinic
  • The Clinical Trial Center
  • Palmetto Clinical Research
  • Alpha Clinical Research
  • Adams Patterson Gynecology and Obstetrics
  • Tennessee Women's Care
  • DiscoveResearch
  • TMC Life Research
  • West Houston Clinical Research Services
  • Urology San Antonio Research
  • The Center for Clinical Studies
  • Utah Clinical Trials
  • Wasatch Clinical Research
  • CARE-ID
  • Tidewater Clinical Reseach
  • Independence Family Medicine Clinical Research
  • Women's Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

2.5% imiquimod cream

3.75% imiquimod cream

Placebo cream

Arm Description

2.5% imiquimod cream applied daily to wart areas 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.

Outcomes

Primary Outcome Measures

Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
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
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.

Full Information

First Posted
August 14, 2008
Last Updated
June 21, 2011
Sponsor
Graceway Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00735462
Brief Title
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Official Title
A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Graceway Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts
Keywords
external genital warts, perianal warts, condylomata acuminata, human papilloma virus, HPV types 6 and 11

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2.5% imiquimod cream
Arm Type
Experimental
Arm Description
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
Arm Title
3.75% imiquimod cream
Arm Type
Experimental
Arm Description
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
Arm Title
Placebo cream
Arm Type
Placebo Comparator
Arm Description
Placebo cream applied daily to wart areas for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
2.5% imiquimod cream
Other Intervention Name(s)
2.5% imiquimod topical cream
Intervention Description
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
3.75% imiquimod cream
Other Intervention Name(s)
3.75% imiquimod topical cream
Intervention Description
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Other Intervention Name(s)
Placebo topical cream
Intervention Description
Placebo cream applied daily to wart areas for up to 8 weeks
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.
Description
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Wu, MD
Organizational Affiliation
Graceway Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Northern Claifornia Research
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
California State University - Chico
City
Chico
State/Province
California
ZIP/Postal Code
95929
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Conant Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Downtown Women's Healthcare
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
PMI Health Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Atlanta Women's Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Howard Brown
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Valley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Women's OB/GYN
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Clayton Research Institute
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63107
Country
United States
Facility Name
Alliance Women's Research
City
Delran
State/Province
New Jersey
ZIP/Postal Code
08075
Country
United States
Facility Name
Women's Health Research Center
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Southwest Clinical Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Boro Park ObGyn
City
New York
State/Province
New York
ZIP/Postal Code
10121
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Complete Healthcare for Women
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Wright State University
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Heartland Health Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
Facility Name
Clinical Trials of America
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Palmetto Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Alpha Clinical Research
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Adams Patterson Gynecology and Obstetrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38102
Country
United States
Facility Name
Tennessee Women's Care
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
DiscoveResearch
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
TMC Life Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
West Houston Clinical Research Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Utah Clinical Trials
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
CARE-ID
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Tidewater Clinical Reseach
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Independence Family Medicine Clinical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23513
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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