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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: Imiquimod A
  • cream, 250 mg/packet, applied daily
• Drug: Imiquimod B
  • cream, 250 mg/packet, applied daily
• Drug: Placebo
  • cream, 250 mg/packet, applied daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• The primary efficacy endpoint is the proportion of subjects achieving complete clearance of all warts (baseline and new) at the EOS.
  • Time Frame: Up to 16 weeks
    Safety Issue?: No

Secondary Measures

• Safety variables include adverse reactions (AEs), local skin reactions (LSRs), and number and duration of rest periods during the Treatment Period.
  • 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 genitalis 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 Sponsor: Graceway Pharmaceuticals, LLC

Overall Clinical Trial Officials and Contacts

Sharon Levy, MD Study Director Graceway Pharmaceuticals  

Overall Contact: Gloria Gosse 215-567-0505 ggosse@tklresearch.com

Information obtained from ClinicalTrials.gov on September 04, 2008

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