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

Genital Warts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674739
• Other study ID #: GW01-0801
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: May 19, 2011
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: May 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: 470
• 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 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:
• Imiquimod
daily topical application 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	Dermatology Practice	Ann Arbor	Michigan
United States	Perimeter Institute for Clinical Research	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Professional Quality Research, The Urology Team	Austin	Texas
United States	Professional Quality Research, Women Partners in Health	Austin	Texas
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	University of Texas Southwestern Medical Center Dermatology Dept	Dallas	Texas
United States	Colorado Medical Research Center	Denver	Colorado
United States	Edinger Medical Group Clinical Research Center	Fountain Valley	California
United States	East Bay Dermatology Medical Group	Fremont	California
United States	Private Practice	Great Neck	New York
United States	Indiana University Infectious Disease Research Group	Indianapolis	Indiana
United States	WILMAX Clinical Research	Mobile	Alabama
United States	Montgomery Women's Health Associates	Montgomery	Alabama
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Alegent Health Clinic	Omaha	Nebraska
United States	Philadelphia Institute of Dermatology	Philadelphia	Pennsylvania
United States	Precision Trials	Phoenix	Arizona
United States	Women's Health Research	Phoenix	Arizona
United States	Private Practice	Purchase	New York
United States	Atlanta North Gynecology	Roswell	Georgia
United States	Progressive Clinical Research	San Antonio	Texas
United States	Coastal Medical Research Group	San Luis Obispo	California
United States	Miami Research Associates	South Miami	Florida
United States	State University of NY Stony Brook	Stony Brook	New York
United States	Discovery Clinical Research	Sunrise	Florida
United States	Premier Pharmaceutical Research	Tempe	Arizona
United States	Torrance Clinical Research	Torrance	California
United States	Visions Clinical Research	Tucson	Arizona

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 With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study	Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.	Up to 16 weeks	No
Secondary	Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.	Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.; Rest period was a temporary interruption of dosing dur to intolerable LSRs.	Up to 16 weeks	Yes
Secondary	Treatment Related Adverse Events	Numbers of subjects in each treatment group reporting one or more adverse events	Up to 16 weeks	Yes