Ignite Creation Date:
2024-05-05 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00674739
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2008-05-07
Brief Title:
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Sponsor:
Graceway Pharmaceuticals LLC
Organization:
Graceway Pharmaceuticals LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Multi-center Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None