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Completed

NCT Number: NCT00735462

Phase 3 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.

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Key information

Conditions

Genital Warts Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NEA Clinic, Jonesboro, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2.5% imiquimod cream

Drug

2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.

Other names: 2.5% imiquimod topical cream

3.75% imiquimod cream

Drug

3.75% imiquimod cream applied daily to wart areas for up to 8 weeks

Other names: 3.75% imiquimod topical cream

placebo cream

Drug

Placebo cream applied daily to wart areas for up to 8 weeks

Other names: Placebo topical cream

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Graceway Pharmaceuticals, LLC

Industry

Registry information

Official study title

A Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2008
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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