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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 ResearchSan Antonio, Texas  78229
NEA ClinicJonesboro, Arkansas  72401
Wright State UniversityDayton, Ohio  45408
University Urology AssociatesNew York, New York  10016
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Southwest Clinical ResearchAlbuquerque, New Mexico  87102
Dermatology Research AssociatesLos Angeles, California  90045
Complete Healthcare for WomenColumbus, Ohio  43231
Piedmont Medical ResearchWinston-Salem, North Carolina  27103
PMI Health Research GroupAtlanta, Georgia  30312
Palmetto Clinical ResearchSummerville, South Carolina  29485
West Houston Clinical Research ServicesHouston, Texas  77055
Northern Claifornia ResearchCarmichael, California  95608
California State University - ChicoChico, California  95929
Conant FoundationSan Francisco, California  94114
Downtown Women's HealthcareDenver, Colorado  80218
Altus ResearchLake Worth, Florida  33461
Atlanta Women's Research InstituteAtlanta, Georgia  30342
Howard BrownChicago, Illinois  60613
Valley Medical CenterFlint, Michigan  48507
Women's OB/GYNSaginaw, Michigan  48604
Clayton Research InstituteSt Louis, Missouri  63107
Alliance Women's ResearchDelran, New Jersey  08075
Women's Health Research CenterLawrenceville, New Jersey  08648
Boro Park ObGynNew York, New York  10121
Crescent Medical ResearchSalisbury, North Carolina  28144
Rapid Medical ResearchCleveland, Ohio  44122
Heartland Health InstituteTulsa, Oklahoma  74105
Clinical Trials of AmericaEugene, Oregon  97401
Westover Heights ClinicPortland, Oregon  97210
The Clinical Trial CenterJenkintown, Pennsylvania  19046
Alpha Clinical ResearchClarksville, Tennessee  37043
Adams Patterson Gynecology and ObstetricsMemphis, Tennessee  38102
Tennessee Women's CareNashville, Tennessee  37203
DiscoveResearchBryan, Texas  77802
TMC Life ResearchHouston, Texas  77054
The Center for Clinical StudiesWebster, Texas  77058
Utah Clinical TrialsSalt Lake City, Utah  84107
Wasatch Clinical ResearchSalt Lake City, Utah  84107
CARE-IDAnnandale, Virginia  22003
Tidewater Clinical ReseachVirginia Beach, Virginia  23456
Independence Family Medicine Clinical ResearchVirginia Beach, Virginia  23513
Women's Clinical Research CenterSeattle, Washington  98105