Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
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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 |
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Recruitment Status :
Completed
First Posted : August 15, 2008
Results First Posted : July 20, 2011
Last Update Posted : July 20, 2011
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 2.5% imiquimod cream
2.5% imiquimod cream applied daily to wart areas for up to 8 weeks
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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 |
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Experimental: 3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
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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 |
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Placebo Comparator: Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks.
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Drug: Placebo cream
Placebo cream applied daily to wart areas for up to 8 weeks
Other Name: Placebo topical cream |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Jason Wu, MD | Graceway Pharmaceuticals |
| 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 |
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external genital warts perianal warts condylomata acuminata human papilloma virus HPV types 6 and 11 |
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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 |