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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Genital Warts Drug: 2.5% imiquimod cream Drug: 3.75% imiquimod cream Drug: Placebo cream Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
Study Start Date : August 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
Drug Information available for: Imiquimod

Arms and Interventions
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Arm Intervention/treatment
Experimental: 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
 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
Experimental: 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
 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
Placebo Comparator: Placebo cream
Placebo 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
Other Name: Placebo topical cream


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735462


Locations
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Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
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Study Director: Jason Wu, MD Graceway Pharmaceuticals
More Information
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Responsible Party: Jason Wu, MD / Executive Director, Product Development, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00735462    
Other Study ID Numbers: GW01-0805
First Posted: August 15, 2008    Key Record Dates
Results First Posted: July 20, 2011
Last Update Posted: July 20, 2011
Last Verified: June 2011
Keywords provided by Graceway Pharmaceuticals, LLC:
external genital warts
perianal warts
condylomata acuminata
human papilloma virus
HPV types 6 and 11
Additional relevant MeSH terms:
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Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers