EUCTR2009-017520-88-DE进行中（未招募）不适用
Ciclosporin vs. Alitretinoin for severe atopic hand dermatitis. A randomized controlled investigator-initiated double-blind trial. - Tocy
Medical Faculty, TU Dresden0 个研究点目标入组 78 人开始时间: 2010年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
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
- •-Male and female Patients age 18 years and = 75 years
- •-Body weight 50 to 100 kg
- •-Chronic hand dermatitis (duration 6 months)
- •-Atopic constitution according to
- •- Erlanger Atopiescore and/or
- •- positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or
- •- elevated serum IgE (> 100 kU/L)
- •-Severe hand dermatitis not responding to treatment with potent topical steroids for at least 4 weeks within the past 6 months due to IGA
- •-Written informed consent
- •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
- •-Participation in other clinical trial within past 4 weeks
- •-Pregnancy/breastfeeding
- •-Women within reproductive age except those women who fulfil at least one of the following criteria throughout the total study and until at least 5 weeks after active study treatment in case of early study termination:
- •-post-menopausal women (12 months physiological amenorrhoea or 6 months amenorrhoea with serum FSH level > 40 mlU/ml),
- •-postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- •-Regular and proper use of at least two methods of contraception, including at least one method of contraception with a failure rate <1% per year (eg, implants, depot preparations, oral contraceptives, IUD).
- •-vasectomy of the partner.
- •-Women within reproductive age, who do not meet all of the following criteria throughout the whole study or – in case of early study termination – up to 5 weeks after active therapy:
- •-The patient understands the teratogenic risk associated with taking the study medication.
- •-The patient understands the need for strict monthly monitoring, the need for a reliable, continuous contraception and the need for regular pregnancy tests throughout the study and – in case of early study termination – up to 5 weeks of active therapy.
- •-The patient is able to adequately and reliably apply methods of contraception.
- •-The patient is informed about the possible consequences of pregnancy and knows that she must immediately contact her physician in case of suspected pregnancy.
- •-The patient gives informed consent about knowing the potential risks and necessary measures to avoid pregnancy.
- •-Blood and/or plasma donation during the whole study period. In case of early study termination blood and plasma donation is not allowed until 1 month after the end of active study treatment
- •-UV-therapy within past 3 months
- •-Concurrent photo-and / or photochemotherapy
- •-Known Hypersensitivity / Intolerance against ciclosporin, alitretinoin or any other ingredients of Immunosporin® or Toctino®
- •-Known Allergy against peanuts or soya
- •-Known Hereditary fructose intolerance
- •-Acute and/or uncontrolled chronic infectious disease
- •-Known Congenital or acquired immune deficiency
- •-Malignant tumor (past or present)
- •-Uncontrolled arterial hypertension (RR systolic = 160 mm Hg and/or RR diastolic= 90 mm Hg despite anti-hypertensive treatment)
- •-Renal insufficiency (Serum creatinine above normal range)
- •-Liver insufficiency (CHILD = Stadium B)
- •-Not sufficiently controlled hyperlipidemia (LDL/HDL ratio > 4 despite medical treatment)
- •-Clinically significant thyroid hypofunction
- •-Known Hypervitaminosis A
- •-Concurrent supplementation of vitamin A or treatment with other retinoids
- •-Concurrent tetracycline therapy
- •-Concurrent therapy with St. John’s wort (Johanniskraut)
- •-Known genetic diseases causing increased UV light sensitivity such as Xeroderma pigmentosum, Cockayne-syndrome, Bloom syndrome
- •-Known Drug- and/or alcohol abuse
- •-Known significant psychiatric morbidity
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