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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety 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 Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety 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 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 With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study

Outcome 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.

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:

GW01-0801

NCT ID:

NCT00674739

Start Date:

May 2008

Completion Date:

July 2009

Related Keywords:

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

Name

Location

Medical College of GeorgiaAugusta, Georgia  30912
Private PracticeStaten Island, New York  10305
Colorado Medical Research CenterDenver, Colorado  80210
Visions Clinical ResearchBoynton Beach, Florida  33472
Miami Research AssociatesMiami, Florida  33173
Women's Health ResearchPhoenix, Arizona  85015
Precision TrialsPhoenix, Arizona  85032
Philadelphia Institute of DermatologyFort Washington, Pennsylvania  19034
WILMAX Clinical ResearchMobile, Alabama  36608
Montgomery Women's Health AssociatesMontgomery, Alabama  36116
Premier Pharmaceutical ResearchTempe, Arizona  85282
Visions Clinical ResearchTucson, Arizona  85712
Edinger Medical Group Clinical Research CenterFountain Valley, California  92708
East Bay Dermatology Medical GroupFremont, California  94538
Coastal Medical Research GroupSan Luis Obispo, California  93405
Torrance Clinical ResearchTorrance, California  90505
Clinicos, LLCColorado Springs, Colorado  80904
Segal Institute for Clinical ResearchNorth Miami, Florida  33161
Discovery Clinical ResearchSunrise, Florida  33316
Perimeter Institute for Clinical ResearchAtlanta, Georgia  30338
Atlanta North GynecologyRoswell, Georgia  30075
Indiana University Infectious Disease Research GroupIndianapolis, Indiana  46202
Dermatology PracticeAnn Arbor, Michigan  48103
Alegent Health ClinicOmaha, Nebraska  68124
State University of NY Stony BrookStony Brook, New York  11794
Professional Quality Research, The Urology TeamAustin, Texas  78759
Professional Quality Research, Women Partners in HealthAustin, Texas  78705
University of Texas Southwestern Medical Center Dermatology DeptDallas, Texas  75390
Progressive Clinical ResearchSan Antonio, Texas  78229