EUCTR2014-001171-31-DE进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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.
- •2. Patients with at least 4 but not more than 10 clinically confirmed AK 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
- •3. Patients with skin type I to IV according to Fitzpatrick
- •4. 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.
- •5. 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.
- •6. Patients who accept to refrain from sunbathing, intense UV-light exposure and the solarium during the study duration.
- •7. 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.
- •8. Patients able (physical ability or supportive person) to apply the study preparations correctly and to follow the study procedure and restrictions
- •Additional inclusion criteria for the patients participating on the sub-clinical lesions sub-study:
- •9. Patients with at least 3 subclinical lesions in the 25 cm² test area (field) clearly separated from each other and the actinic keratoses lesions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Subjects that have received treatment for AK within the treatment area in the 3 months previous to Visit 1 (screening).
- •2. Subjects that have received prohibited pharmacological or non-pharmacological treatments for any indication other than AK within the treatment area before randomization (Visit 2).
- •3. Subjects that have received prohibited systemic treatments for any indication before randomization (Visit 2).
- •4. Subjects taking phenytoin, methotrexate or sulfonylurea.
- •5. 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).
- •6. 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).
- •7. Subjects that suffer from any kind of photodermatoses
- •8. Subjects that have evidence of clinically significant unstable medical conditions.
- •9. 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
- •10. Subjects with allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, and/or methylmethacrylate
- •11. Subjects with dihydropyrimidine dehydrogenase deficiency (DPD deficiency).
- •12. Subjects that are currently participating or have participated within the 8 weeks prior to Visit 1 in another clinical trial.
- •13. Patients with known drug or alcohol abuse as assessed by the investigator within the 2 years prior to Visit 1.
- •14. Subject is institutionalized because of legal or regulatory order.
研究者
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