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Sponsored by: |
Graceway Pharmaceuticals, LLC |
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Information provided by: | Graceway Pharmaceuticals, LLC |
ClinicalTrials.gov Identifier: | NCT00674739 |
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.
Condition | Intervention | Phase |
---|---|---|
Genital Warts |
Drug: Imiquimod A Drug: Imiquimod B Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 450 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Imiquimod A
cream, 250 mg/packet, applied daily
|
2: Active Comparator |
Drug: Imiquimod B
cream, 250 mg/packet, applied daily
|
3: Placebo Comparator |
Drug: Placebo
cream, 250 mg/packet, applied daily
|
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sharon Levy, MD | Graceway Pharmaceuticals, LLC |
Responsible Party: | Graceway Pharmaceuticals, LLC ( Sharon Levy, MD / Vice President, Product Development ) |
Study ID Numbers: | GW01-0801 |
Study First Received: | May 7, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00674739 |
Health Authority: | United States: Food and Drug Administration |
external genital warts perianal warts condylomata acuminata venereal warts HPV types 6 and 11 |
Sexually Transmitted Diseases, Viral Skin Diseases Interferons Condyloma Imiquimod Virus Diseases Skin Diseases, Infectious |
Warts Condylomata Acuminata Condyloma acuminatum Sexually Transmitted Diseases Papillomavirus Infections DNA Virus Infections |
Skin Diseases, Viral Interferon Inducers Neoplasms Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Tumor Virus Infections Pharmacologic Actions |