NCT02289768已完成3 期
Multicentre, Randomized, Parallel, Double-Blind, Vehicle Controlled Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In The Field-Directed Treatment Of Actinic Keratoses Grade I To II (Field Cancerization)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 14
- 主要终点
- Percentage of patients with complete clinical clearance of actinic keratosis lesions in the treatment field
研究概览
简要总结
The main purpose of this vehicle-controlled study is to determine the efficacy and safety of a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected area once daily for 12 weeks.
A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on subclinical actinic keratosis lesions in a subset of patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or non-pregnant, non-lactating (in the last 3 months) female aged between 18 and 85 years (both inclusive). Women of childbearing potential will follow specific study requirements.
- •Patients with at least 4 but not more than 10 clinically confirmed actinic keratoses lesions grade I or II (according to Olsen EA et al. 1991) within a field of cancerization of 25 cm² in the face/forehead or bald scalp.
- •Patients with skin type I to IV (according to Fitzpatrick Skin Types)
- •Patients free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may interfere with area examination or final evaluation.
- •Patients in good health condition or free of medical conditions that may interfere with the study results as confirmed by a physical examination, medical history and laboratory analysis.
- •Patients who accept to refrain from sunbathing, intense UV-light exposure and the solarium during the study duration.
- •Patients willing to stop using moisturizers and topical treatments with anti-aging products, vitamins A, C, and/or E containing ointments and gels and green tea preparations in the treatment area.
- •Patients able (physical ability or supportive person) to apply the study preparations correctly and to follow the study procedure and restrictions.
- •Patients with at least 3 subclinical lesions in the 25 cm² test area (field) clearly separated from each other and the actinic keratoses lesions (additional inclusion criteria for the patients participating on the sub-clinical lesions sub-study).
排除标准
- •Subjects that have received treatment for actinic keratoses within the treatment area in the 3 months previous to Visit 1 (screening).
- •Subjects that have received prohibited pharmacological or non-pharmacological treatments for any indication other than actinic keratoses within the treatment area before randomization (Visit 2).
- •Subjects that have received prohibited systemic treatments for any indication before randomization (Visit 2).
- •Subjects taking phenytoin, methotrexate or sulfonylurea.
- •Subjects with dermatological diseases in the treatment area or surrounding area that may be exacerbated by the study treatment or may interfere the study assessments (e.g. psoriasis, eczema).
- •Subjects that have currently malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).
- •Subjects that suffer from any kind of photodermatoses.
- •Subjects that have evidence of clinically significant unstable medical conditions.
- •Subjects with known hypersensitivity to any of the trial drugs (5-fluorouracil, salicylic acid), to ingredients of the trial formulation, or to drugs of similar chemical classes
- •Subjects with allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, and/or methylmethacrylate.
- •Subjects with dihydropyrimidine dehydrogenase deficiency (DPD deficiency).
- •Subjects that are currently participating or have participated within the 8 weeks prior to Visit 1 in another clinical trial.
- •Patients with known drug or alcohol abuse as assessed by the investigator within the 2 years prior to Visit
- •Subject is institutionalized because of legal or regulatory order.
研究组 & 干预措施
5-fluorouracil/salicylic acid
Experimental
Actikerall® solution (5-fluorouracil 0.5%, salicylic acid 10.0%) applied to the affected area once-daily for 12 weeks
干预措施: 5-fluorouracil/salicylic acid (Drug)
Vehicle
Placebo Comparator
Vehicle solution applied to the affected area once-daily for 12 weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of patients with complete clinical clearance of actinic keratosis lesions in the treatment field
时间窗: Week 20
Complete Clinical Clearance is defined as no clinically visible actinic keratosis lesions in the selected treatment area
次要结局
- Percentage of patients with partial clinical clearance of actinic keratosis lesions in the treatment field(Week 20)
- Percentage change from baseline in the total number of actinic keratosis lesions(Week 20)
- Global assessment of efficacy by the physician (Physician Global Assessment)(Week 20)
- Change from baseline in total score of the Dermatology Life Quality Index (DLQI)(Week 20)
- Total score of the patients´ treatment satisfaction questionnaire for medication (TSQM)(Week 20)
- Percentage of patients with complete clearance of three pre-defined subclinical actinic keratosis lesions(Week 20)
- Percentage change from baseline in the three selected actinic keratosis subclinical lesions(Week 20)
- Percentage of patients for which the clearance of one pre-defined representative clinical actinic keratosis lesion is confirmed by reflectance confocal microscopy(Week 20)
- The number of patients with adverse events(Week 20)
研究者
研究点 (14)
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