NCT01358851已完成2 期
A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Histological status (AK diagnosis and grade) of one predefined target lesion
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent.
- •Men and women aged between 18 and 85 years inclusive.
- •Have a general good and stable health condition as confirmed by a physical examination and by medical history.
- •Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target lesions of moderate to severe intensity within the face/forehead or bald scalp
- •Skin type I to IV according to Fitzpatrick's .
- •Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
- •Physical ability to apply the study preparation correctly and to follow the study restrictions and visit.
- •Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception
排除标准
- •Have received treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial.
- •Have known hypersensitivity to the ingredients
- •Are subjects under immunosuppressive therapy.
- •Having coagulation defects which are inherited or acquired
- •Have evidence of clinically significant, unstable medical conditions
- •Have currently other malignant or benign tumors of the skin within the treatment area
- •Subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea.
- •Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin)
- •Are known to be pregnant or lactating (currently or within the past 3 months).
- •Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment
- •Are currently or within the past 8 weeks participating in another clinical study.
- •Have active chemical dependency or alcoholism as assessed by the investigator.
- •Subject is institutionalized because of legal or regulatory order.
研究组 & 干预措施
1
Experimental
Drug Las41005
干预措施: LAS41005 (Drug)
2
Other
Cryotherapy
干预措施: Cryotherapy (Procedure)
结局指标
主要结局
Histological status (AK diagnosis and grade) of one predefined target lesion
时间窗: Screening and 8 weeks after last treatment
Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade.
次要结局
- Total Actinic keratoses (AK)lesion count at each visit(day 1, day 21, day 42 and day 98.)
研究者
研究点 (4)
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