CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 470 enrolled
Drug / intervention
Imiquimod +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00674739
NCT00674739Phase 3Completed

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts

Graceway Pharmaceuticals, LLC·interventional·Posted May 8, 2008·Updated May 24, 2011

In Brief

A Phase 3 clinical trial evaluating Imiquimod, 3.75% imiquimod cream, and 1 other intervention for Genital Warts. Completed, enrolled 470 participants across 30 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenital Warts
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2008
Enrollment StartMay 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.2 years ago

Interventions

Imiquimoddrug

daily topical application for up to 8 weeks

3.75% imiquimod creamdrug

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

placebo creamdrug

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