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

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00735462
First received: August 14, 2008
Last updated: June 21, 2011
Last verified: June 2011

August 14, 2008
June 21, 2011
August 2008
July 2009   (final data collection date for primary outcome measure)
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
The primary efficacy endpoint is the proportion of subjects achieving complete clearance of all warts (baseline and new) at the end of study. [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00735462 on ClinicalTrials.gov Archive Site
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 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]

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.

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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
A Safety and Effectiveness 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Genital Warts
  • Drug: 2.5% imiquimod cream
    2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.
    Other Name: 2.5% imiquimod topical cream
  • Drug: 3.75% imiquimod cream
    3.75% imiquimod cream applied daily to wart areas for up to 8 weeks
    Other Name: 3.75% imiquimod topical cream
  • Drug: Placebo cream
    Placebo cream applied daily to wart areas for up to 8 weeks
    Other Name: Placebo topical cream
  • Experimental: 2.5% imiquimod cream
    2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
    Intervention: Drug: 2.5% imiquimod cream
  • Experimental: 3.75% imiquimod cream
    3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
    Intervention: Drug: 3.75% imiquimod cream
  • Placebo Comparator: Placebo cream
    Placebo cream applied daily to wart areas for up to 8 weeks.
    Intervention: Drug: Placebo cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735462
GW01-0805
No
Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
Graceway Pharmaceuticals, LLC
Not Provided
Study Director: Jason Wu, MD Graceway Pharmaceuticals
Graceway Pharmaceuticals, LLC
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP