Safety and Effectiveness 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: NCT00674739 |
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Recruitment Status :
Completed
First Posted : May 8, 2008
Results First Posted : May 18, 2011
Last Update Posted : May 24, 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: Imiquimod Drug: 3.75% imiquimod cream Drug: placebo cream | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 470 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | July 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: imiquimod cream
2.5% imiquimod cream applied daily to wart area for up to 8 weeks
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Drug: Imiquimod
daily topical application for up to 8 weeks
Other Name: imiquimod 2.5% topical creram |
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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 matching cream |
- Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study [ Time Frame: Up to 16 weeks ]Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.
- Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period. [ Time Frame: Up to 16 weeks ]
Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.
Rest period was a temporary interruption of dosing dur to intolerable LSRs.
- Treatment Related Adverse Events [ Time Frame: Up to 16 weeks ]Numbers of subjects in each treatment group reporting one or more adverse events
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 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): NCT00674739
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| Study Director: | Jason Wu, MD | Graceway Pharmaceuticals |
| Responsible Party: | Jason Wu, MD / Exective Director, Product Development, Graceway Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT00674739 |
| Other Study ID Numbers: |
GW01-0801 |
| First Posted: | May 8, 2008 Key Record Dates |
| Results First Posted: | May 18, 2011 |
| Last Update Posted: | May 24, 2011 |
| Last Verified: | May 2011 |
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external genital warts perianal warts condylomata acuminata venereal warts HPV types 6 and 11 |
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Warts Condylomata Acuminata Papillomavirus Infections DNA Virus Infections Virus Diseases Infections Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Communicable Diseases Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |