Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
研究概览
简要总结
The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3
- •Colposcopy with fully visible transformation zone and lesion
- •Safe Contraception
- •Signed Informed Consent
- •Negative urine pregnancy test
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study
- •Signed the written informed consent
排除标准
- •Women who are pregnant or lactating or become pregnant during the conduct of the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- •Participating in another clinical trial within 30 days
- •Malignancy
- •Immunosuppression (medication, illness)
- •HIV- or Hepatitis infection
研究组 & 干预措施
Imiquimod
topical therapy for 16 weeks with imiquimod containing therapy
干预措施: Topical imiquimod therapy (Drug)
Placebo
topical therapy for 16 weeks with a placebo containing vaginal suppository
干预措施: Topical imiquimod therapy (Drug)
结局指标
主要结局
To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
时间窗: 20 weeks after treatment start
次要结局
- HPV-Clearance, feasibility and adverse event profile and drop-out rate(20 weeks after treatment start)