Phase 3
N=511
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Genital Warts
Bottom Line
View on ClinicalTrials.gov: NCT00735462 ↗Enrolled (actual)
511
Serious AEs
1.8%
Results posted
Jul 2011
Primary outcome: Primary: Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. — 0.248; 0.294; 0.09 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 2.5% imiquimod cream (Drug); 3.75% imiquimod cream (Drug); Placebo cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Graceway Pharmaceuticals, LLC
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study. |
0.248; 0.294; 0.09 | — |
| SECONDARY 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 |
37; 40; 3; 123; 148; 41 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00735462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.