EUCTR2010-022244-20-DE进行中（未招募）不适用
Double-blind, randomized, vehicle- and comparator-controlled, multicenter trial to evaluate the efficacy and safety of LAS41007 in the treatment of actinic keratosis - LAS41007 Phase III
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
- 824
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. Signed and dated written informed consent,
- •2. Caucasian male and female patients,
- •3. Aged = 18 years,
- •4. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception ,
- •5. Have at least 6 but no more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al, 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp,
- •6. The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm,
- •7. The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm,
- •8. The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2),
- •9. Patient consents to take punch biopsies in the TA.
- •Additionally, to be eligible for randomization, a patient must comply with the following criterion:
- •10. Diagnosis of AK histologically confirmed by result of punch biopsy taken at screening visit (classification according to Röwert-Huber, 2007).
- •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 107
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 717
排除标准
- •1.Have known hypersensitivity, intolerance or allergies against diclofenac sodium or other ingredients of the IMPs (hyaluronic acid, benzyl alcohol, poly ethyleneglycol monomethyl ether) and other non-steroidal anti-inflammatory agents,
- •2.Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
- •3.Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs,
- •4.Have evidence of clinically significant or unstable medical conditions such as:
- •-metastatic tumor or tumor with high probability of metastatic spread,
- •-heart failure (NYHA class III or higher),
- •-immunosuppressive disorder (e.g. HIV, patients following organ transplantation)
- •-hematologic, hepatic, renal, neurologic or endocrine disorder,
- •-collagen-vascular disorder (e.g. cerebro-vascular disorder or other bleedings),
- •-gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage),
- •5.Have currently and within the past 3 months other malignant tumors of the skin in the treatment areas (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma),
- •8.Are known to be pregnant or lactating (currently or within the past 3 months),
- •10.Have received the following topical treatments for any indication in the target area (defined as the whole face, including the forehead and the bald scalp) within 6 weeks before treatment with IMP: topical retinoids, topical steroids, topical 5-fluorouracil preparations, topical immunomodulators, topical diclofenac,
- •11.Have received the following physical treatments in the TAs within the designated period before treatment with IMP: treatment (6 weeks), surgical excision - except biopsy for diagnostic confirmation (6 weeks), cryo-, thermo- or chemodestruction (6 weeks), photodynamic therapy (6 weeks), curettage (4 weeks),
- •16.Anticoagulative therapy, e.g. with cumarines (e.g. phenprocoumon - e.g. trade name Marcumar® - or heparines throughout the interventional phase of the study. Treatment with ASA at a dose not exceeding 100 mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed,
- •17.Patients having any significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment areas that may cause difficulty with examination or final evaluation
研究者
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