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


Phase 3
12 Years
N/A
Not Enrolling
Both
Genital Warts

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

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

Outcome Description:

The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.

Outcome Time Frame:

Up to 16 weeks

Safety Issue:

No

Principal Investigator

Jason Wu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

GW01-0805

NCT ID:

NCT00735462

Start Date:

August 2008

Completion Date:

July 2009

Related Keywords:

  • Genital Warts
  • external genital warts
  • perianal warts
  • condylomata acuminata
  • human papilloma virus
  • HPV types 6 and 11
  • Condylomata Acuminata
  • Warts

Name

Location

Urology San Antonio Research San Antonio, Texas  78229
NEA Clinic Jonesboro, Arkansas  72401
Wright State University Dayton, Ohio  45408
University Urology Associates New York, New York  10016
Altman Dermatology Associates Arlington Heights, Illinois  60004
Southwest Clinical Research Albuquerque, New Mexico  87102
Dermatology Research Associates Los Angeles, California  90045
Complete Healthcare for Women Columbus, Ohio  43231
Piedmont Medical Research Winston-Salem, North Carolina  27103
PMI Health Research Group Atlanta, Georgia  30312
Palmetto Clinical Research Summerville, South Carolina  29485
West Houston Clinical Research Services Houston, Texas  77055
Northern Claifornia Research Carmichael, California  95608
California State University - Chico Chico, California  95929
Conant Foundation San Francisco, California  94114
Downtown Women's Healthcare Denver, Colorado  80218
Altus Research Lake Worth, Florida  33461
Atlanta Women's Research Institute Atlanta, Georgia  30342
Howard Brown Chicago, Illinois  60613
Valley Medical Center Flint, Michigan  48507
Women's OB/GYN Saginaw, Michigan  48604
Clayton Research Institute St Louis, Missouri  63107
Alliance Women's Research Delran, New Jersey  08075
Women's Health Research Center Lawrenceville, New Jersey  08648
Boro Park ObGyn New York, New York  10121
Crescent Medical Research Salisbury, North Carolina  28144
Rapid Medical Research Cleveland, Ohio  44122
Heartland Health Institute Tulsa, Oklahoma  74105
Clinical Trials of America Eugene, Oregon  97401
Westover Heights Clinic Portland, Oregon  97210
The Clinical Trial Center Jenkintown, Pennsylvania  19046
Alpha Clinical Research Clarksville, Tennessee  37043
Adams Patterson Gynecology and Obstetrics Memphis, Tennessee  38102
Tennessee Women's Care Nashville, Tennessee  37203
DiscoveResearch Bryan, Texas  77802
TMC Life Research Houston, Texas  77054
The Center for Clinical Studies Webster, Texas  77058
Utah Clinical Trials Salt Lake City, Utah  84107
Wasatch Clinical Research Salt Lake City, Utah  84107
CARE-ID Annandale, Virginia  22003
Tidewater Clinical Reseach Virginia Beach, Virginia  23456
Independence Family Medicine Clinical Research Virginia Beach, Virginia  23513
Women's Clinical Research Center Seattle, Washington  98105