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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
Not Enrolling
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:


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:


Principal Investigator

Jason Wu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals


United States: Food and Drug Administration

Study ID:




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



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