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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Imiquimod
  • daily topical application for up to 8 weeks
• Drug: 3.75% imiquimod cream
  • 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
• Drug: placebo cream
  • placebo cream applied daily to wart areas for up to 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: imiquimod cream
  • 2.5% imiquimod cream applied daily to wart area for up to 8 weeks
• Experimental: 3.75% imiquimod cream
  • 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
• Placebo Comparator: placebo cream
  • placebo cream applied daily to wart areas for up to 8 weeks

Primary Measures

• Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
  • Time Frame: Up to 16 weeks
    Safety Issue?: No

Secondary Measures

• Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
  • Time Frame: Up to 16 weeks
    Safety Issue?: Yes
• Treatment Related Adverse Events
  • Time Frame: Up to 16 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Medicis Global Service Corporation Industry

Overall Clinical Trial Officials and Contacts

Jason Wu, MD Study Director Medicis Global Service Corporation  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674739

Study ID Number: GW01-0801

ClinicalTrials.gov Identifier: NCT00674739

Health Authority: United States: Food and Drug Administration