Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Difference in recurrence rates between the two arms
研究概览
简要总结
AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection.
Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.
100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign and date a written consent document
- •Male and female patients >= 18 years of age
- •Negative urine/serum pregnancy test
- •Indication for surgical therapy of anal HPV lesions
排除标准
- •Participation in another clinical study with experimental therapy
- •Diagnosis and therapy of HPV associated lesions in the last 12 months
- •Known intolerance of hypersensitivity to Imiquimod
- •Women who are pregnant of lactating
研究组 & 干预措施
Interventional Arm
Imiquimod 5% cream therapy Fulguration
干预措施: Imiquimod 5% cream (Drug)
Interventional Arm
Imiquimod 5% cream therapy Fulguration
干预措施: Fulguration (Procedure)
Placebo Arm
Placebo cream therapy Fulguration
干预措施: Placebo cream (Drug)
Placebo Arm
Placebo cream therapy Fulguration
干预措施: Fulguration (Procedure)
结局指标
主要结局
Difference in recurrence rates between the two arms
时间窗: 12 months
Recurrence is evaluated by clinical examination (proctoscopy)
次要结局
- CD4 (cluster of differentiation 4) cell count(12 months)
研究者
Irmgard E Kronberger, MD
Leading Consultent
Medical University Innsbruck