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Safety and Effectiveness 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
Imiquimod
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, venereal warts, 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 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

  • WILMAX Clinical Research
  • Montgomery Women's Health Associates
  • Women's Health Research
  • Precision Trials
  • Premier Pharmaceutical Research
  • Visions Clinical Research
  • Edinger Medical Group Clinical Research Center
  • East Bay Dermatology Medical Group
  • Coastal Medical Research Group
  • Torrance Clinical Research
  • Clinicos, LLC
  • Colorado Medical Research Center
  • Visions Clinical Research
  • Segal Institute for Clinical Research
  • Miami Research Associates
  • Discovery Clinical Research
  • Perimeter Institute for Clinical Research
  • Medical College of Georgia
  • Atlanta North Gynecology
  • Indiana University Infectious Disease Research Group
  • Dermatology Practice
  • Alegent Health Clinic
  • Private Practice
  • Private Practice
  • State University of NY Stony Brook
  • Philadelphia Institute of Dermatology
  • Professional Quality Research, Women Partners in Health
  • Professional Quality Research, The Urology Team
  • University of Texas Southwestern Medical Center Dermatology Dept
  • Progressive Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

imiquimod cream

3.75% imiquimod cream

placebo cream

Arm Description

2.5% imiquimod cream applied daily to wart area 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 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.

Secondary Outcome Measures

Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
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.
Treatment Related Adverse Events
Numbers of subjects in each treatment group reporting one or more adverse events

Full Information

First Posted
May 7, 2008
Last Updated
May 19, 2011
Sponsor
Graceway Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00674739
Brief Title
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 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, venereal warts, 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
470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
imiquimod cream
Arm Type
Experimental
Arm Description
2.5% imiquimod cream applied daily to wart area 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)
Imiquimod
Other Intervention Name(s)
imiquimod 2.5% topical creram
Intervention Description
daily topical application 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 matching cream
Intervention Description
placebo cream applied daily to wart areas for up to 8 weeks
Primary Outcome Measure Information:
Title
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
Description
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.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Description
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.
Time Frame
Up to 16 weeks
Title
Treatment Related Adverse Events
Description
Numbers of subjects in each treatment group reporting one or more adverse events
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 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
WILMAX Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Montgomery Women's Health Associates
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Premier Pharmaceutical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Visions Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Edinger Medical Group Clinical Research Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
East Bay Dermatology Medical Group
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Coastal Medical Research Group
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Discovery Clinical Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Perimeter Institute for Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Atlanta North Gynecology
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Indiana University Infectious Disease Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dermatology Practice
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Alegent Health Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Private Practice
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Private Practice
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States
Facility Name
State University of NY Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Philadelphia Institute of Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19144
Country
United States
Facility Name
Professional Quality Research, Women Partners in Health
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Professional Quality Research, The Urology Team
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
University of Texas Southwestern Medical Center Dermatology Dept
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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