CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
2.5% imiquimod cream +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/NCT00735462
NCT00735462Phase 3Completed

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

Graceway Pharmaceuticals, LLC·interventional·Posted Aug 15, 2008·Updated Jul 20, 2011

In Brief

A Phase 3 clinical trial evaluating 2.5% imiquimod cream, 3.75% imiquimod cream, and 1 other intervention for Genital Warts. Completed, enrolled 511 participants across 43 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
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.9 years ago

Interventions

2.5% imiquimod creamdrug

2.5% imiquimod cream applied daily to wart areas 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