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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735462
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC

Tracking Information
First Submitted Date  ICMJE August 14, 2008
First Posted Date  ICMJE August 15, 2008
Results First Submitted Date  ICMJE April 24, 2011
Results First Posted Date  ICMJE July 20, 2011
Last Update Posted Date July 20, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. [ Time Frame: Up to 16 weeks ]
The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Official Title  ICMJE A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Genital Warts
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2011)
511
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2008)
450
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00735462
Other Study ID Numbers  ICMJE GW01-0805
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
Study Sponsor  ICMJE Graceway Pharmaceuticals, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jason Wu, MD Graceway Pharmaceuticals
PRS Account Graceway Pharmaceuticals, LLC
Verification Date June 2011

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