NCT01231854终止4 期
Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
研究概览
简要总结
The purpose of this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 Atopiescore1 and/or
- •positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or
- •elevated serum IgE
- •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
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
研究组 & 干预措施
Ciclosporingroup
Active Comparator
干预措施: Ciclosporin (Drug)
Alitretinoingroup
Active Comparator
干预措施: Alitretinoin (Drug)
结局指标
主要结局
Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
次要结局
- Time to complete or almost complete clearance according to IGA in both groups
- Proportion of patients with complete or almost complete clearance according to the Patients Global Assessment (PGA) within 12 weeks and 24 weeks of active therapy
- Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups
- Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups
- Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D)
- Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale)
- Proportion of patients with relapse (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance
- Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups
- Mean utilization of topical steroids within the follow-up period in both groups
- In patients with atopic dermatitis on the body: measured percentage of patients with at least 50% improvement in disease severity with the active therapy using the SCORAD.
- Tolerability and safety in both study groups
研究者
研究点 (1)
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