EUCTR2008-000459-88-DE进行中（未招募）1 期
Prospective, randomized study of the efficacy of photodynamic therapy in actinic keratosis - PDT in AK
niv.-Prof. Dr. Hans F. Merk, Dept. of Dermatology, University Hospital, RWTH Aachen University0 个研究点目标入组 100 人开始时间: 2008年10月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Patients who comply with the following criteria will be selected for the study:
- •- Willing and able to sign informed consent form.
- •- Men aged between 45 to 85 years.
- •- Postmenopausal women (at least 3 years postmenopausal, 45 to 85 years)
- •- Histologically or clinically confirmed diagnosis of actinic keratosis grade I (mild actinic keratosis: better palpable [skin roughness], than visible) and grade II (moderate actinic keratosis: palpable [roughness] and visible [red macula or papule with mild keratosis]) of the face and scalp. A histopathologic assessment will be performed in case of doubt to exclude basal cell carcinoma, squamous cell carcinoma, actinic porokeratosis or lentigo-maligna.
- •- Have a good and stable health condition on the basis of the entrance examination and patient history.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients may not participate if they meet any of the following criteria:
- •- Women and men under the age of 45 years.
- •- Premenopausal, pregnant or breastfeeding women (currently or within the past 3 months)
- •- History of or clinically proven photodermatoses, porphyria, hypersensitivity to porphyrins or generally known photosensitivity.
- •- Use of topical medications such as topical steroids, retinoids, imiquimod or 5-fluorouracil within 3 months before the start of the study.
- •- Immunosuppressive medication (corticosteroids, methotrexate, cyclosporine, azathioprine, chemotherapy, immunotherapy ect.) within 3 months before the start of the study.
- •- Laser resurfacing or chemical peelings of the areas to be treated within 2 months before inclusion in the study.
- •-Treatment with photosenzitising drugs like psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolons, fibrates, phytotherapy with St. John`s wart, arnica, valerian or topically applied phototoxic substances like tar, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal red, or acridine.
- •- Known allergies, hypersensitivity reactions or intolerance to the drug and the ingredients of the 10% BF-200 ALA-gel: soy lecithine, polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, propylene glycole, sodium benzoate.
- •- Simultaneous participation in other studies.
- •- Other causes, which lead occording to the investigator to an exclusion from the study.
- •- Servere systemic disease (egg. cardiovascular (NYHA class III, IV), hematologic, hepatic, renal, endocrine, metastatic tumour disease)
- •- Lately diagnosed premalignant or malignant skin disease in the treatment area (hypertrophic, hyperkeratotic actinic keratosis grade III, Cornu cutaneum-like lesions, malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
- •- Severe local reaction (massive erythema with pronounced edema, erosions and pustular reaction), a second PDT will not be performed.
研究者
相似试验
已完成
4 期
Evaluating the effect of a new interventional method for Herpes PaiCTRI/2018/03/012693niversity College of Medical Sciences40
已完成
不适用
A randomised controlled trial of the efficacy of patients receiving a brief supervised self-help training package by practice nurses in primary care settings.Minor mental health problemsMental and Behavioural DisordersISRCTN37811364HS R&D Regional Programme Register - Department of Health (UK)1,600
已完成
不适用
Prospective and randomized study on the efficacy of novel hypoglycemic type 2 diabetes agent ipragliflozin to serum glycemic control and cardiovascular risk factorsJPRN-UMIN000014422Fukui-ken Saiseikai Hospital100
尚未招募
不适用
A study to determine analgesic effects of femoral nerve block for positioning for spinal anesthesia and for post operative analgesiaCTRI/2021/08/035919Sardar Patel Medical College Bikaner
尚未招募
2 期
Care of wounds due to healing foot wound with your own blood product and daily care.CTRI/2018/11/016470AIIMS New Delhi