EUCTR2011-001697-26-DK进行中（未招募）1 期
Optimising outpatient care in mild to moderate psoriasis by a newly developed ‘Topical Treatment Optimising Programme’ - an international study using Daivobet®/Dovobet® Gel (‘PSO-TOP’) - PSO-TOP
Professor Reich0 个研究点目标入组 1,956 人开始时间: 2011年12月6日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,956
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 aged at least 18 years
- •- Mild to moderate active plaque psoriasis with a PGA = 2 on the 7 point scale by Langley and Ellis and a Body Surface Area (BSA) of = 10%
- •- Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol / 0.5 mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
- •- Written informed consent to participate in the study has been given prior to any study related procedures
- •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
- •- Severe renal insufficiency
- •- Severe hepatic disorders
- •- Known hyper calcaemia
- •- Erythrodermic, exfoliative, pustular or guttate psoriasis
- •- Facial or genital psoriasis
- •- Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®
- •- Pregnant and/or breast-feeding women or women of childbearing potential who do not agree to use one of the following contraceptive methods for the duration of the study and at least 1 week after the last dose of study medication: Intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
- •- Hypersensitivity to the active substances or to any of the excipients
- •- Suspected non-compliance with the clinical study procedures
- •- Current participation in another clinical study
- •- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0):
- •etanercept – within 4 weeks prior to Visit 1 (week 0)
- •adalimumab, alefacept, infliximab – within 2 months prior to Visit 1 (week 0)
- •ustekinumab – within 4 months prior to Visit 1 (week 0)
- •experimental products – within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0)
- •- Phototherapy within the following time periods prior to Visit 1 (week 0):
- •PUVA – within 4 weeks prior to Visit 1 (week 0)
- •UV-B – within 2 weeks prior to Visit 1 (week 0)
研究者
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