Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts

Genital Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735462
• Other study ID #: GW01-0805
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2008
• Last updated: June 21, 2011
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2011
• Source: Graceway Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• Warts

Intervention

Drug:
• 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
• 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
• Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks

Locations

Country	Name	City	State
United States	Southwest Clinical Research	Albuquerque	New Mexico
United States	CARE-ID	Annandale	Virginia
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Atlanta Women's Research Institute	Atlanta	Georgia
United States	PMI Health Research Group	Atlanta	Georgia
United States	DiscoveResearch	Bryan	Texas
United States	Northern Claifornia Research	Carmichael	California
United States	Howard Brown	Chicago	Illinois
United States	California State University - Chico	Chico	California
United States	Alpha Clinical Research	Clarksville	Tennessee
United States	Rapid Medical Research	Cleveland	Ohio
United States	Complete Healthcare for Women	Columbus	Ohio
United States	Wright State University	Dayton	Ohio
United States	Alliance Women's Research	Delran	New Jersey
United States	Downtown Women's Healthcare	Denver	Colorado
United States	Clinical Trials of America	Eugene	Oregon
United States	Valley Medical Center	Flint	Michigan
United States	Palmetto Clinical Research	Greer	South Carolina
United States	TMC Life Research	Houston	Texas
United States	West Houston Clinical Research Services	Houston	Texas
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	NEA Clinic	Jonesboro	Arkansas
United States	Altus Research	Lake Worth	Florida
United States	Women's Health Research Center	Lawrenceville	New Jersey
United States	Dermatology Research Associates	Los Angeles	California
United States	Adams Patterson Gynecology and Obstetrics	Memphis	Tennessee
United States	Tennessee Women's Care	Nashville	Tennessee
United States	Boro Park ObGyn	New York	New York
United States	University Urology Associates	New York	New York
United States	Westover Heights Clinic	Portland	Oregon
United States	Women's OB/GYN	Saginaw	Michigan
United States	Crescent Medical Research	Salisbury	North Carolina
United States	Utah Clinical Trials	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Urology San Antonio Research	San Antonio	Texas
United States	Conant Foundation	San Francisco	California
United States	Women's Clinical Research Center	Seattle	Washington
United States	Clayton Research Institute	St Louis	Missouri
United States	Heartland Health Institute	Tulsa	Oklahoma
United States	Independence Family Medicine Clinical Research	Virginia Beach	Virginia
United States	Tidewater Clinical Reseach	Virginia Beach	Virginia
United States	The Center for Clinical Studies	Webster	Texas
United States	Piedmont Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.	The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.	Up to 16 weeks	No
Secondary	Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period	Treatment related defined as "probably related" or "related" by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.; Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction.	Up to 16 weeks	Yes