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

Phase 3
12 Years
Not Enrolling
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:


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:


Principal Investigator

Jason Wu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals


United States: Food and Drug Administration

Study ID:




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



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