Prospective, Randomized, Partly Blinded, in Part Placebo-controlled, Multicenter, Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 10
- 主要终点
- Number of patients with complete clinical clearance in the treated area at the end of trial
研究概览
简要总结
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
详细描述
Prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from AK. Patients were observed for efficacy, local tolerability and safety. A total of 14 sites in Switzerland and Germany enrolled male and female patients over 18 years of age with clinically diagnosed AK lesions Patients were randomized to receive resiquimod gel (Treatment Arms 1, 2, 3, 4, or 5) or matching vehicle (Treatment Arms 1-Pla, 2-Pla, or 3-Pla):
Treatment Arms 1, 2 and 3: The patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo).
Treatment Arms 4 and 5: The patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male or nonpregnant, nonlactating female, ≥18 years
- •A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion)
- •AK-lesions on balding scalp, forehead or face
排除标准
- •Known allergy or hypersensitivity to any of the trial gel ingredients
- •Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments
- •Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer
研究组 & 干预措施
Resiquimod Gel 0.03% or placebo
Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once
干预措施: Resiquimod 0.03% (Drug)
Resiquimod Gel 0.03% or placebo
Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once
干预措施: placebo (Drug)
Resiquimod or placebo
Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once
干预措施: Resiquimod 0.03% (Drug)
Resiquimod or placebo
Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once
干预措施: placebo (Drug)
Resiquimod or vehicle
Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once
干预措施: Resiquimod 0.03% (Drug)
Resiquimod or vehicle
Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once
干预措施: placebo (Drug)
Resiquimod gel 0.01%
Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up
干预措施: Resiquimod 0.01% (Drug)
Resiquimod gel 0.03%
Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up
干预措施: Resiquimod 0.03% (Drug)
结局指标
主要结局
Number of patients with complete clinical clearance in the treated area at the end of trial
时间窗: 8 weeks after a maximal treatment period of 8 weeks
次要结局
- Evaluation of adverse events (AEs) and serious adverse events (SAEs)(up to 24 weeks)
- Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales(up to 24 weeks)
- Number of patients with partial clearance(8 weeks after a maximal treatment period of 8 weeks)
- Evaluation of systemic tolerability [hematology, blood chemistry, vital signs](up to 24 weeks)