A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 28
- 主要终点
- Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
imiquimod cream
2.5% imiquimod cream applied daily to wart area for up to 8 weeks
干预措施: Imiquimod (Drug)
3.75% imiquimod cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
干预措施: 3.75% imiquimod cream (Drug)
placebo cream
placebo cream applied daily to wart areas for up to 8 weeks
干预措施: placebo cream (Drug)
结局指标
主要结局
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
时间窗: 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.
次要结局
- Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.(Up to 16 weeks)
- Treatment Related Adverse Events(Up to 16 weeks)