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

NCT00674739 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2011-05-24

Study results available
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Summary

The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.

External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.

Conditions

  • Genital Warts

Interventions

DRUG

Imiquimod

daily topical application for up to 8 weeks

DRUG

3.75% imiquimod cream

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.

DRUG

placebo cream

placebo cream applied daily to wart areas for up to 8 weeks

Sponsors & Collaborators

  • Graceway Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Jason Wu, MD · Graceway Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674739 on ClinicalTrials.gov